SBI ARTFIX— 510(k) K071656
Substantially EquivalentSmall Bone Innovations, Inc.
FDA 510(k) clearance K071656 for SBI ARTFIX, Substantially Equivalent on 2007-08-27. Applicant: Small Bone Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Small Bone Innovations, Inc.
- Product code
- Code HWC
- 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 HWC
view allMore clearances from Small Bone Innovations, Inc.
view all- K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
- K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
- K102180 — RHEAD RADIAL HEAD EXTENDED STEMS
- K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
- K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.