PROSTHETIC CEMENT REMOVER
FDA 510(k) clearance K904180 · decided 1990-11-20
Clearance details
- K-number
- K904180
- Device name
- PROSTHETIC CEMENT REMOVER
- Applicant
- Origin Medsystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-11
- Decision date
- 1990-11-20
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LZV
- Device class
- 2
- Regulation number
- 888.4580
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (K891472) | Implant Technology, Inc. | 1989-05-02 |
| PROSTHETIC CEMENT REMOVER (K890285) | Albert K. Chin | 1989-04-19 |
Recalls involving this device
No recalls on record reference this clearance.