FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEO KIRSCHNER WIRE
K Number: K922193
·
Decision Jul 23, 1992
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
9
Review Days
73
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Basic Information
- Device Name
- OSTEO KIRSCHNER WIRE
- K Number
- K922193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteo AG
- Date Received
- May 11, 1992
- Decision Date
- July 23, 1992
- Product Code
- HTY
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by Osteo AG
| K Number | Device Name | ||
|---|---|---|---|
| K933340 | OSTEO INTERLOCKING-COMPRESSION NAIL | Jun 30, 1994 | Substantially Equivalent |
| K922196 | OSTEO TIBIA NAIL | Jul 23, 1992 | Substantially Equivalent |
| K922195 | OSTEO FEMORAL NAIL | Jul 23, 1992 | Substantially Equivalent |
| K922194 | OSTEO STEINMANN PIN | Jul 23, 1992 | Substantially Equivalent |
| K920149 | OSTEO EX-FI-RE | Apr 9, 1992 | Substantially Equivalent |
| K920037 | OSTEO COMPRESSION HIP SCREW | Mar 11, 1992 | Substantially Equivalent |
| K914374 | OSTEO CERCLAGE WIRE | Dec 30, 1991 | Substantially Equivalent |
| K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | Nov 7, 1991 | Substantially Equivalent |