OSTEO COMPRESSION HIP SCREW
FDA 510(k) clearance K920037 · decided 1992-03-11
Clearance details
- K-number
- K920037
- Device name
- OSTEO COMPRESSION HIP SCREW
- Applicant
- Osteo AG
- Decision
- Substantially Equivalent
- Date received
- 1992-01-06
- Decision date
- 1992-03-11
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- HRC
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Greenwood, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.