STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE
FDA 510(k) clearance K984200 · decided 1999-01-21
Clearance details
- K-number
- K984200
- Device name
- STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE
- Applicant
- R. Thomas Grotz, M.D., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-24
- Decision date
- 1999-01-21
- Days to decision
- 58 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
No recalls on record reference this clearance.