Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC
Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC (Florida): 510(k) cleared for Response Ortho Solutions, LLC. Its amount of 30 is below the median of 138 (10th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-04, 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: 30 · 10th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263083 |
| Device | Response Ortho Smart Fixator - Hexapod System |
| Applicant | Response Ortho Solutions, LLC |
| Specialty / panel | Orthopedic |
| Product code | KTT |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-02 |
| Decision date | 2026-10-02 |
| Review time (days) | 30 |
| Third-party review | No |
| Applicant location | Boynton Beach, FL, US |
| amount percentile | 10th of 414 (median 138, 0.2x median) |
| Peer records CSV (16 FL records) | 🔒 Click to unlock → |
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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: 2026-10-02
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC and 16 Florida peers
- Florida FDAPulse records like this one: 16
- Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC's amount: 10th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 30-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 33 days ago.
What is the FDAPulse record for Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC in Florida?
Response Ortho Smart Fixator - Hexapod System (K263083) by Response Ortho Solutions, LLC was cleared on 2026-10-02 after 30 days of review.
How does Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC compare to other Florida FDAPulse records?
Its amount of 30 is below the median (10th percentile); smaller records often move faster and face less competition. It is 33 days old, still within a typical 45-day follow-up window.
Response Ortho Smart Fixator - Hexapod System (K263083) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Response Ortho Smart Fixator - Hexapod System (K263083) | FL | 2026-10-02 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
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- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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