ARTHROPLASTY MALLET
FDA 510(k) clearance K872209 · decided 1987-06-23
Clearance details
- K-number
- K872209
- Device name
- ARTHROPLASTY MALLET
- Applicant
- New England Surgical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-09
- Decision date
- 1987-06-23
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HXL
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rockland, MA, 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 |
|---|---|---|
| MALLET, SURGICAL (K882349) | Treace Medical, Inc. | 1988-06-23 |
| MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. (K871195) | Military Engineering, Inc. | 1987-04-06 |
Recalls involving this device
No recalls on record reference this clearance.