STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
FDA 510(k) clearance K973031 · decided 1997-11-03
Clearance details
- K-number
- K973031
- Device name
- STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
- Applicant
- R. Thomas Grotz, M.D., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-14
- Decision date
- 1997-11-03
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- MRI
- Device class
- 1
- Regulation number
- 890.3490
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| ORLAU SWIVEL WALKER (K923880) | Mopac, Ltd. | 1996-09-30 |
Recalls involving this device
No recalls on record reference this clearance.