System, Cement Removal Extraction
The Cement Removal Extraction System (product code LZV) is an orthopedic surgical instrument system used during revision joint replacement surgery to remove existing bone cement from the intramedullary canal and joint space, allowing for re-implantation of new prosthetic components. Regulated under 21 CFR 888.4580 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Orthopedic specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- LZV
- Device Class
- FDA class 2
- Regulation Number
- 888.4580
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K021502 | OSCAR, MODEL OE3000 | Jun 06, 2002 | Substantially Equivalent | Orthosonics, Ltd. |
| K961101 | STRYKER CEMENT REMOVAL SYSTEM | Jul 15, 1996 | Substantially Equivalent | Stryker Corp. |
| K930629 | ACRYL-X II SYSTEM | Jan 21, 1994 | Substantially Equivalent | Sonokinetics, Inc. |
| K904156 | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS | Nov 27, 1990 | Substantially Equivalent | Origin Medsystems, Inc. |
| K904180 | PROSTHETIC CEMENT REMOVER | Nov 20, 1990 | Substantially Equivalent | Origin Medsystems, Inc. |
| K891472 | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR | May 02, 1989 | Substantially Equivalent | Implant Technology, Inc. |
| K890285 | PROSTHETIC CEMENT REMOVER | Apr 19, 1989 | Substantially Equivalent | Albert K. Chin |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.