ORLAU SWIVEL WALKER
FDA 510(k) clearance K923880 · decided 1996-09-30
Clearance details
- K-number
- K923880
- Device name
- ORLAU SWIVEL WALKER
- Applicant
- Mopac, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-31
- Decision date
- 1996-09-30
- Days to decision
- 1522 days
- Clearance type
- Traditional
- Product code
- MRI
- Device class
- 1
- Regulation number
- 890.3490
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Eau Claire, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE (K973031) | R. Thomas Grotz, M.D., Inc. | 1997-11-03 |
Recalls involving this device
No recalls on record reference this clearance.