DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
FDA 510(k) clearance K862945 · decided 1986-08-20
Clearance details
- K-number
- K862945
- Device name
- DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-05
- Decision date
- 1986-08-20
- Days to decision
- 15 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Wilmington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.