ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc.
ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc. (Arizona): 510(k) cleared for Costa Surgical, Inc. Its amount of 110 is below the median of 138 (40th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 36/100. 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: 110 · 40th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 5 related AZ FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261892 |
| Device | ProRib Fixation System |
| Applicant | Costa Surgical, Inc. |
| Specialty / panel | Orthopedic |
| Product code | HRS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-05 |
| Decision date | 2026-09-23 |
| Review time (days) | 110 |
| Third-party review | No |
| Applicant location | Chandler, AZ, US |
| amount percentile | 40th of 414 (median 138, 0.8x 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: 2026-09-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (AZ first): VENTANA MMR IHC Panel (K260776) · Reprocessed BRK Transseptal Needle (K262917) · Class II recall Z-0158-2027 · Class II recall Z-0085-2027 · Class II recall Z-3275-2026 · 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: ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc. and 6 Arizona peers
- Arizona FDAPulse records like this one: 6
- ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc.'s amount: 40th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Arizona peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 110-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc. in Arizona?
ProRib Fixation System (K261892) by Costa Surgical, Inc. was cleared on 2026-09-23 after 110 days of review.
How does ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc. compare to other Arizona FDAPulse records?
Its amount of 110 is below the median (40th percentile); smaller records often move faster and face less competition. It is 42 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.
ProRib Fixation System (K261892) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| ProRib Fixation System (K261892) | AZ | 2026-09-23 |
| 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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