Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE (Delaware): 510(k) cleared for Brainlab SE. Its amount of 90 is below the median of 138 (31st percentile). Dated 35 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 90 · 31th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262257 |
| Device | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine |
| Applicant | Brainlab SE |
| Specialty / panel | Neurology |
| Product code | OLO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-02 |
| Decision date | 2026-09-30 |
| Review time (days) | 90 |
| Third-party review | No |
| Applicant location | Munich, DE |
| amount percentile | 31th of 414 (median 138, 0.7x median) |
| Peer records CSV (25 DE records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE + all 25 DE records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE's amount: 31st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 90-day review: this device is a strong predicate for similar products.
- Posted 35 days ago.
What is the FDAPulse record for Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE in Delaware?
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257) by Brainlab SE was cleared on 2026-09-30 after 90 days of review.
How does Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE compare to other Delaware FDAPulse records?
Its amount of 90 is below the median (31th percentile); smaller records often move faster and face less competition. It is 35 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257) | DE | 2026-09-30 |
| KARL STORZ Flexible Video Neuro-Endoscope (K260581) | DE | 2026-10-14 |
| Tontarra Punches and Rongeurs (K260446) | DE | 2026-09-15 |
Related records
- 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC
- cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.
- Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.
- Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.
- cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.
- Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC
- Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.
- FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.
- Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited
- KARL STORZ Flexible Video Neuro-Endoscope (K260581): 510(k) cleared for Karl Storz SE & CO. KG
- Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC
- Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Neurology devices
More Delaware public-record feeds
Delaware Public Education Organization Directory Pulse in Delaware Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Delaware FEMA Hazard Mitigation Project Tracker in Delaware Federal Alcohol Permit Holder Directory in Delaware New NSF Research Awards by Institution in Delaware School & Library E-Rate Contracts Up for Rebid in Delaware New Grants by Vendor Procurement Need in Delaware Carrier Out-of-Service Alerts in Delaware
How to monitor Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE and peer neurology records
Get new FDAPulse records like Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.