510(k) K021502
- Device
- OSCAR, MODEL OE3000
- Applicant
- ORTHOSONICS, LTD.
- 510(k) number
- K021502
- Product code
- LZV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-06
- Date received
- 2002-05-09
- Regulation
- 888.4580
- Classification name
- System, Cement Removal Extraction
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- T. WHIT ATHEY
- Address
- 2305 Gold Mine Rd. Brookeville MD US 20833 20833
FDA Registration Numbers#
- 3012663306
- 3036690185
- 2025102
- 2183449
- 9680825
Source Documents#
Other 510(k) Records For Product Code LZV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
summary
FDA Review#
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