SBI ULNAR HEAD IMPLANT— 510(k) K061146
Substantially EquivalentSmall Bone Innovations, Inc.
FDA 510(k) clearance K061146 for SBI ULNAR HEAD IMPLANT, Substantially Equivalent on 2006-07-19. Applicant: Small Bone Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Small Bone Innovations, Inc.
- Product code
- Code KXE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3810
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- New York, NY, US
Recent devices under product code KXE
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- K102180 — RHEAD RADIAL HEAD EXTENDED STEMS
- K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
- K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM
Recalls naming K061146
K-number listed on FDA's recall record- Z-2427-2015 — uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
- Z-2430-2015 — Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061146.
Data sourced from openFDA. This site is unofficial and independent of the FDA.