Stryker Cement Removal System
FDA 510(k) K961101 · Stryker Corp.
510(k) numberK961101
Submission
- Device name
- Stryker Cement Removal System
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- March 19, 1996
- Decision date
- July 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K021502 | Oscar, Model OE3000LZV · Special | Orthosonics, Ltd. | 06/06/2002SE |
| 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 |
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Questions and answers
When was Stryker Cement Removal System cleared by the FDA?
Stryker Cement Removal System (K961101) received a 510(k) decision of Substantially Equivalent on July 15, 1996, 118 days after the submission was received.
What is the product code of K961101?
The FDA product code is LZV – System, Cement Removal Extraction, a Class II (moderate risk) device regulated under 21 CFR 888.4580.