FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
K Number: K913559
·
Decision Nov 7, 1991
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
- K Number
- K913559
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteo AG
- Date Received
- August 9, 1991
- Decision Date
- November 7, 1991
- Product Code
- HSZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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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 |
| K922193 | OSTEO KIRSCHNER WIRE | 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 |