ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc.
ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc. (Massachusetts): 510(k) cleared for ZSFab, Inc. Its amount of 28 is below the median of 138 (6th percentile). Dated 34 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: 28 · 6th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263113 |
| Device | ZSAlign Cervical Interbody System |
| Applicant | ZSFab, Inc. |
| Specialty / panel | Orthopedic |
| Product code | OVE |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-04 |
| Decision date | 2026-10-02 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Waltham, MA, US |
| amount percentile | 6th of 414 (median 138, 0.2x median) |
| Peer records CSV (41 MA 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: ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc. and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc.'s amount: 6th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 34 days ago.
What is the FDAPulse record for ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc. in Massachusetts?
ZSAlign Cervical Interbody System (K263113) by ZSFab, Inc. was cleared on 2026-10-02 after 28 days of review.
How does ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc. compare to other Massachusetts FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is 34 days old, still within a typical 45-day follow-up window.
ZSAlign Cervical Interbody System (K263113) vs. top 2 peers
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