MALLET, SURGICAL
FDA 510(k) clearance K882349 · decided 1988-06-23
Clearance details
- K-number
- K882349
- Device name
- MALLET, SURGICAL
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-07
- Decision date
- 1988-06-23
- Days to decision
- 16 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
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Treace Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTHROPLASTY MALLET (K872209) | New England Surgical Instrument Corp. | 1987-06-23 |
| MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. (K871195) | Military Engineering, Inc. | 1987-04-06 |
Recalls involving this device
No recalls on record reference this clearance.