Impactor
An impactor is a handheld orthopedic surgical instrument used to drive implants, prosthetic components, or fixation hardware into bone by delivering controlled impact force, typically through hammer strikes. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject only to general controls. Product code HWA falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HWA
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | Jan 25, 1994 | Substantially Equivalent | Mira, Inc. |
| K864422 | RAYLOR(TM) MALLET | Nov 24, 1986 | Substantially Equivalent | Cedar Surgical, Inc. |
| K841627 | MALLET | Aug 27, 1984 | Substantially Equivalent | Plastafil, Inc. |
| K770205 | CEMENT CHISELS | Feb 08, 1977 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 304 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 304 registration numbers. Click on an entry to view related FDA registrations.