Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH
Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH (Delaware): 510(k) cleared for MK Medical GmbH. Its amount of 120 is below the median of 138 (45th percentile). Dated 13 days ago, it is in the active follow-up window. Score 42/100. 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: 120 · 45th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262126 |
| Device | Cerclage Wires;K-wires;Steinmann Pins |
| Applicant | MK Medical GmbH |
| Specialty / panel | Orthopedic |
| Product code | HTY |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-24 |
| Decision date | 2026-10-22 |
| Review time (days) | 120 |
| Third-party review | No |
| Applicant location | Emmingen-Liptingen, DE |
| amount percentile | 45th of 414 (median 138, 0.9x median) |
| Peer records CSV (25 DE 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: 2026-10-22
- 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: Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH's amount: 45th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 120-day review: this device is a strong predicate for similar products.
- Posted 13 days ago.
What is the FDAPulse record for Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH in Delaware?
Cerclage Wires;K-wires;Steinmann Pins (K262126) by MK Medical GmbH was cleared on 2026-10-22 after 120 days of review.
How does Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH compare to other Delaware FDAPulse records?
Its amount of 120 is below the median (45th percentile); smaller records often move faster and face less competition. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
Cerclage Wires;K-wires;Steinmann Pins (K262126) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Cerclage Wires;K-wires;Steinmann Pins (K262126) | DE | 2026-10-22 |
| 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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- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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