LZV
7 FDA 510(k) clearances · Product code
81 daysmedian time to decision
347 days90th percentile
7clearances measured
FDA profile
- Official device name
- System, Cement Removal Extraction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 1996: 3 · 1997: 2 · 1999: 2 · 2004: 2 · 2005: 2 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OSCAR, MODEL OE3000 (K021502) | Orthosonics, Ltd. | 2002-06-06 |
| STRYKER CEMENT REMOVAL SYSTEM (K961101) | Stryker Corp. | 1996-07-15 |
| ACRYL-X II SYSTEM (K930629) | Sonokinetics, Inc. | 1994-01-21 |
| ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS (K904156) | Origin Medsystems, Inc. | 1990-11-27 |
| PROSTHETIC CEMENT REMOVER (K904180) | Origin Medsystems, Inc. | 1990-11-20 |
| IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (K891472) | Implant Technology, Inc. | 1989-05-02 |
| PROSTHETIC CEMENT REMOVER (K890285) | Albert K. Chin | 1989-04-19 |
Track LZV automatically
Every clearance here is in the API, with alerts when new ones post.