INTRAMEDULLARY ROD
FDA 510(k) clearance K861183 · decided 1986-08-11
Clearance details
- K-number
- K861183
- Device name
- INTRAMEDULLARY ROD
- Applicant
- The Deca Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-31
- Decision date
- 1986-08-11
- Days to decision
- 133 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.