Pusher, Socket
A socket pusher is a handheld orthopedic instrument used to seat or advance an acetabular cup or other socket-type implant component firmly into its bone preparation during hip or other joint replacement surgery. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject to general controls. Product code HXO falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HXO
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K885305 | ACETABULAR CUP PUSHER/IMPACTOR | Feb 08, 1989 | Substantially Equivalent | Cobot Medical Corp. |
| K803165 | ACETABULAR CEMENT COMPRESSOR | Dec 31, 1980 | Substantially Equivalent | Zimmer, Inc. |
| K771072 | INSERTEO, META.-PHAL.&THUMB CARPO-META | Jun 27, 1977 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 74 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 74 registration numbers. Click on an entry to view related FDA registrations.