SBI TITANIUM THREADED PIN— 510(k) K071540
Substantially EquivalentSmall Bone Innovations, Inc.
FDA 510(k) clearance K071540 for SBI TITANIUM THREADED PIN, Substantially Equivalent on 2007-08-08. Applicant: Small Bone Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Small Bone Innovations, Inc.
- 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
- New York, NY, US
Recent devices under product code JDW
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- K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
- K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.