FDA product code LZV: System, Cement Removal Extraction
LZV is the FDA product code for system, cement removal extraction. It is a Class II device, regulated under 21 CFR 888.4580 and reviewed by the Orthopedic panel. FDA has cleared 7 510(k) submissions under LZV, from 6 different applicants. The average 510(k) review took 112 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | System, Cement Removal Extraction |
| Device class | Class II |
| Regulation | 21 CFR 888.4580 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LZV clearance
Top LZV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Origin Medsystems, Inc. | 2 | 1990-11-27 |
| Orthosonics, Ltd. | 1 | 2002-06-06 |
| Stryker Corp. | 1 | 1996-07-15 |
| Sonokinetics, Inc. | 1 | 1994-01-21 |
| Implant Technology, Inc. | 1 | 1989-05-02 |
1 more applicants have LZV clearances. See the full list in Caduvo.
Most recent LZV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021502 | Orthosonics, Ltd. | OSCAR, MODEL OE3000 | 2002-06-06 | 28 |
| K961101 | Stryker Corp. | STRYKER CEMENT REMOVAL SYSTEM | 1996-07-15 | 118 |
| K930629 | Sonokinetics, Inc. | ACRYL-X II SYSTEM | 1994-01-21 | 347 |
| K904156 | Origin Medsystems, Inc. | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS | 1990-11-27 | 81 |
| K904180 | Origin Medsystems, Inc. | PROSTHETIC CEMENT REMOVER | 1990-11-20 | 70 |
Recalls for LZV devices
openFDA lists no recalls for product code LZV.
Frequently asked questions
What is FDA product code LZV?
LZV is the FDA product code for system, cement removal extraction. It is a Class II device, regulated under 21 CFR 888.4580 and reviewed by the Orthopedic panel.
What device class is LZV?
Class II, regulation 21 CFR 888.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LZV?
Across 7 cleared submissions the average was 112 days from receipt to decision (median 81).
Which companies have the most LZV clearances?
Origin Medsystems, Inc. (2); Orthosonics, Ltd. (1); Stryker Corp. (1); Sonokinetics, Inc. (1); Implant Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LZV
- Run a recall and safety report across every LZV manufacturer
- Watch product code LZV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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