DANNINGER ORTHOPAEDIC AWL
FDA 510(k) clearance K875223 · decided 1988-02-17
Clearance details
- K-number
- K875223
- Device name
- DANNINGER ORTHOPAEDIC AWL
- Applicant
- Danninger Medical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-22
- Decision date
- 1988-02-17
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- HWJ
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Concord, CA, 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 |
|---|---|---|
| CROSS MEDICAL PRODUCT PEDICLE AWL (K895587) | Cross Medical Products, Inc. | 1990-01-04 |
| ACROMED AWL/PUNCH, DEPTH GAUGE (K880045) | Buckman Co., Inc. | 1988-02-17 |
| ACROMED WALLIE-HEINIG TROCHAR (K870779) | Buckman Co., Inc. | 1987-03-09 |
Recalls involving this device
No recalls on record reference this clearance.