KIRSCHNER (K-WIRE), STEINMAN PINS— 510(k) K945670
Substantially EquivalentBrasseler USA I, L.P.
FDA 510(k) clearance K945670 for KIRSCHNER (K-WIRE), STEINMAN PINS, Substantially Equivalent on 1995-03-07. Applicant: Brasseler USA I, L.P.. Device class: 2.
Clearance details
- Applicant
- Brasseler USA I, L.P.
- Product code
- Code JDW
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Savannah, GA, US
Recent devices under product code JDW
view allMore clearances from Brasseler USA I, L.P.
view allAdverse events under product code JDW
product code JDW- Injury
- 717
- Total
- 717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K945670
K-number listed on FDA's recall record- Z-0707-2022 — Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
- Z-0884-2020 — Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945670.
Data sourced from openFDA. This site is unofficial and independent of the FDA.