ENDOPEARL WITH THREADER
FDA 510(k) clearance K993339 · decided 1999-12-10
Clearance details
- K-number
- K993339
- Device name
- ENDOPEARL WITH THREADER
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-05
- Decision date
- 1999-12-10
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- MAI
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.