Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc.
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc. (California): 510(k) cleared for Alphatec Spine, Inc. Its amount of 83 is below the median of 138 (24th percentile). Dated 14 days ago, it is in the active follow-up window. Score 42/100. 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: 83 · 24th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262646 |
| Device | Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System |
| Applicant | Alphatec Spine, Inc. |
| Specialty / panel | Orthopedic |
| Product code | MAX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-30 |
| Decision date | 2026-10-21 |
| Review time (days) | 83 |
| Third-party review | No |
| Applicant location | Carlsbad, CA, US |
| amount percentile | 24th of 414 (median 138, 0.6x median) |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc.'s amount: 24th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 83-day review: this device is a strong predicate for similar products.
- Posted 14 days ago.
What is the FDAPulse record for Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc. in California?
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646) by Alphatec Spine, Inc. was cleared on 2026-10-21 after 83 days of review.
How does Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc. compare to other California FDAPulse records?
Its amount of 83 is below the median (24th percentile); smaller records often move faster and face less competition. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646) | CA | 2026-10-21 |
| 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 |
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