Oscar, Model OE3000
FDA 510(k) K021502 · Orthosonics, Ltd.
510(k) numberK021502
Submission
- Device name
- Oscar, Model OE3000
- Applicant
- Orthosonics, Ltd.
Brookeville, MD, US - Received
- May 9, 2002
- Decision date
- June 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZV – System, Cement Removal Extraction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
Other 510(k)s with product code LZV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961101 | Stryker Cement Removal SystemLZV · Traditional | Stryker Corp. | 07/15/1996SE |
| K930629 | Acryl-X II SystemLZV · Traditional | Sonokinetics, Inc. | 01/21/1994SE |
| K904156 | Origin(Tm) Cement Extract Syst Std-Pr/Spl-Pr KitsLZV · Traditional | Origin Medsystems, Inc. | 11/27/1990SE |
| K904180 | Prosthetic Cement RemoverLZV · Traditional | Origin Medsystems, Inc. | 11/20/1990SE |
| K891472 | Implant Technology Bone Cement ExtractorLZV · Traditional | Implant Technology, Inc. | 05/02/1989SE |
| K890285 | Prosthetic Cement RemoverLZV · Traditional | Albert K. Chin | 04/19/1989SE |
More from Albert K. Chin
Questions and answers
When was Oscar, Model OE3000 cleared by the FDA?
Oscar, Model OE3000 (K021502) received a 510(k) decision of Substantially Equivalent on June 6, 2002, 28 days after the submission was received.
What is the product code of K021502?
The FDA product code is LZV – System, Cement Removal Extraction, a Class II (moderate risk) device regulated under 21 CFR 888.4580.