Product code LZV
- Device name
- System, Cement Removal Extraction
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.4580
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021502 | OSCAR, MODEL OE3000 | Orthosonics, Ltd. | 2002-06-06 |
| K961101 | STRYKER CEMENT REMOVAL SYSTEM | Stryker Corp. | 1996-07-15 |
| K930629 | ACRYL-X II SYSTEM | Sonokinetics, Inc. | 1994-01-21 |
| K904156 | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS | Origin Medsystems, Inc. | 1990-11-27 |
| K904180 | PROSTHETIC CEMENT REMOVER | Origin Medsystems, Inc. | 1990-11-20 |
| K891472 | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR | Implant Technology, Inc. | 1989-05-02 |
| K890285 | PROSTHETIC CEMENT REMOVER | Albert K. Chin | 1989-04-19 |
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| 08404535024371 | Axiom Blades | Peter Brasseler Holdings, LLC | 2026-04-29 |
| 08404535024401 | Axiom Blades | Peter Brasseler Holdings, LLC | 2026-04-29 |
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| 05060201560340 | OSCAR | ORTHOSONICS LIMITED | 2017-07-10 |