Mallet
A surgical mallet is a hammer-like instrument used in general and plastic surgery to drive chisels, osteotomes, or orthopedic instrumentation by delivering controlled force during bone cutting or implant insertion procedures. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating minimal risk and general controls only. Product code HXL falls under the General and Plastic Surgery medical specialty.
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Basic Information
- Product Code
- HXL
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K882349 | MALLET, SURGICAL | Jun 23, 1988 | Substantially Equivalent | Treace Medical, Inc. |
| K872209 | ARTHROPLASTY MALLET | Jun 23, 1987 | Substantially Equivalent | New England Surgical Instrument Corp. |
| K871195 | MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. | Apr 06, 1987 | Substantially Equivalent | Military Engineering, Inc. |
FEI Numbers
This FDA classification entry is associated with 200 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 200 registration numbers. Click on an entry to view related FDA registrations.