FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEO COMPRESSION HIP SCREW
K Number: K920037
·
Decision Mar 11, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
65
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Basic Information
- Device Name
- OSTEO COMPRESSION HIP SCREW
- K Number
- K920037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteo AG
- Date Received
- January 6, 1992
- Decision Date
- March 11, 1992
- Product Code
- HRC
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HRC | Sterilizer, Soft-Lens, Thermal, Battery-Powered | FDA class 2 | Ophthalmic |
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 |
| K914374 | OSTEO CERCLAGE WIRE | Dec 30, 1991 | Substantially Equivalent |
| K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | Nov 7, 1991 | Substantially Equivalent |