STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
FDA 510(k) clearance K965111 · decided 1997-02-18
Clearance details
- K-number
- K965111
- Device name
- STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
- Applicant
- R. Thomas Grotz, M.D., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-20
- Decision date
- 1997-02-18
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
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