APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.
APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. (Colorado): 510(k) cleared for Paragon 28, Inc. Its amount of 187 is above the median of 138 (66th percentile). Dated 28 days ago, it is in the active follow-up window. Score 48/100. 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: 187 · 66th percentile of 414 FDAPulse records · 1.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related CO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261120 |
| Device | APEX 3D S Diamond Tibia |
| Applicant | Paragon 28, Inc. |
| Specialty / panel | Orthopedic |
| Product code | HSN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-03 |
| Decision date | 2026-10-07 |
| Review time (days) | 187 |
| Third-party review | No |
| Applicant location | Englewood, CO, US |
| amount percentile | 66th of 414 (median 138, 1.4x median) |
| Peer records CSV (9 CO 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: 2026-10-07
- 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: APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. and 9 Colorado peers
- Colorado FDAPulse records like this one: 9
- APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.'s amount: 66th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Colorado peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 187-day review, longer than typical.
- Posted 28 days ago.
What is the FDAPulse record for APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. in Colorado?
APEX 3D S Diamond Tibia (K261120) by Paragon 28, Inc. was cleared on 2026-10-07 after 187 days of review.
How does APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. compare to other Colorado FDAPulse records?
Its amount of 187 sits in the upper half (66th percentile) of 414 records; the median is 138. It is 28 days old, still within a typical 45-day follow-up window.
APEX 3D S Diamond Tibia (K261120) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| APEX 3D S Diamond Tibia (K261120) | CO | 2026-10-07 |
| 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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