ALPHA ORTHOPAEDICS AT2 SYSTEM
FDA 510(k) clearance K082956 · decided 2008-12-18
Clearance details
- K-number
- K082956
- Device name
- ALPHA ORTHOPAEDICS AT2 SYSTEM
- Applicant
- Alpha Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2008-10-03
- Decision date
- 2008-12-18
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hayward, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.