27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF
FDA 510(k) clearance K851786 · decided 1985-07-09
Clearance details
- K-number
- K851786
- Device name
- 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF
- Applicant
- Artiberia
- Decision
- Substantially Equivalent
- Date received
- 1985-04-25
- Decision date
- 1985-07-09
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- LGG
- Device class
- 1
- Regulation number
- 888.5980
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Antonio, TX, 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 |
|---|---|---|
| PLASTER STAND (K870100) | Orthopedic Systems, Inc. | 1987-01-28 |
| MODULAR EXTREMITY CASTING SUPPORT (K834384) | Buckman Co., Inc. | 1984-01-30 |
Recalls involving this device
No recalls on record reference this clearance.