CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd.
CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd. (Illinois): 510(k) cleared for CarboFix Orhtopedics , Ltd. Its amount of 30 is below the median of 138 (10th percentile). Dated 26 days ago, it is in the active follow-up window. 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: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263154 |
| Device | CarboClear® Cervical Navigated Instruments |
| Applicant | CarboFix Orhtopedics , Ltd. |
| Specialty / panel | Neurology |
| Product code | OLO |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-09 |
| Decision date | 2026-10-09 |
| Review time (days) | 30 |
| Third-party review | No |
| Applicant location | Herzeliya, IL |
| amount percentile | 10th of 414 (median 138, 0.2x median) |
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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: 2026-10-09
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (IL first): SmartIPL_NI System (K241973) · Hyperdrive 35 Guidewire (K253146) · Tempus ECG-MR (K254297) · Ecomed Disposable Administration Sets (K254123) · TumorSight Risk (K260023) · Browse all by state and category →
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: CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd.'s amount: 10th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (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 26 days ago.
What is the FDAPulse record for CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd. in Illinois?
CarboClear® Cervical Navigated Instruments (K263154) by CarboFix Orhtopedics , Ltd. was cleared on 2026-10-09 after 30 days of review.
How does CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd. compare to other Illinois FDAPulse records?
Its amount of 30 is below the median (10th percentile); smaller records often move faster and face less competition. It is 26 days old, still within a typical 45-day follow-up window.
CarboClear® Cervical Navigated Instruments (K263154) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| CarboClear® Cervical Navigated Instruments (K263154) | IL | 2026-10-09 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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