KMI WRIST FUSION SYSTEM
FDA 510(k) clearance K991873 · decided 1999-08-17
Clearance details
- K-number
- K991873
- Device name
- KMI WRIST FUSION SYSTEM
- Applicant
- Kinetikos Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-02
- Decision date
- 1999-08-17
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.