Prosthetic Cement Remover
FDA 510(k) K904180 · Origin Medsystems, Inc.
510(k) numberK904180
Submission
- Device name
- Prosthetic Cement Remover
- Applicant
- Origin Medsystems, Inc.
San Mateo, CA, US - Received
- September 11, 1990
- Decision date
- November 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K021502 | Oscar, Model OE3000LZV · Special | Orthosonics, Ltd. | 06/06/2002SE |
| 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 |
| K891472 | Implant Technology Bone Cement ExtractorLZV · Traditional | Implant Technology, Inc. | 05/02/1989SE |
| K890285 | Prosthetic Cement RemoverLZV · Traditional | Albert K. Chin | 04/19/1989SE |
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| K972685 | Origin Ligator DeviceGCJ · Traditional | 10/01/1997SE |
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| K965121 | CannulaHET · Traditional | 03/20/1997SE |
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| K962104 | Airlift Balloon Retracton SystemGCJ · Traditional | 09/11/1996SE |
| K962005 | Extrahand Balloon RetractorGCJ · Traditional | 08/12/1996SE |
| K960936 | Resposable Trocar System [5MM, 5MM Short, 10MM and 12MM Sizes]HET · Traditional | 07/24/1996SE |
| K960637 | 5MM EndoscopeGCJ · Traditional | 06/14/1996SE |
Questions and answers
When was Prosthetic Cement Remover cleared by the FDA?
Prosthetic Cement Remover (K904180) received a 510(k) decision of Substantially Equivalent on November 20, 1990, 70 days after the submission was received.
What is the product code of K904180?
The FDA product code is LZV – System, Cement Removal Extraction, a Class II (moderate risk) device regulated under 21 CFR 888.4580.