OSCAR, MODEL OE3000
FDA 510(k) clearance K021502 · decided 2002-06-06
Clearance details
- K-number
- K021502
- Device name
- OSCAR, MODEL OE3000
- Applicant
- Orthosonics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-09
- Decision date
- 2002-06-06
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LZV
- Device class
- 2
- Regulation number
- 888.4580
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Brookeville, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Orthosonics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.