Implant Technology Bone Cement Extractor
FDA 510(k) K891472 · Implant Technology, Inc.
510(k) numberK891472
Submission
- Device name
- Implant Technology Bone Cement Extractor
- Applicant
- Implant Technology, Inc.
Secaucus, NJ, US - Received
- March 15, 1989
- Decision date
- May 2, 1989
- 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 |
| K904180 | Prosthetic Cement RemoverLZV · Traditional | Origin Medsystems, Inc. | 11/20/1990SE |
| K890285 | Prosthetic Cement RemoverLZV · Traditional | Albert K. Chin | 04/19/1989SE |
More from Albert K. Chin
| 510(k) | Device | Decision |
|---|---|---|
| K921525 | Hip Joint Metal/Polymer Semi-Constrained ProthesisLPH · Traditional | 01/11/1995SE |
| K915617 | LSF Ha Coated Femoral HipMEH · Traditional | 05/28/1992SE |
| K920021 | LSF Total Hip System - Muller-Type Acetabular CupJDI · Traditional | 03/25/1992SE |
| K913616 | LSF Diagnostic Related Group Cemented HipJDI · Traditional | 11/07/1991SE |
| K902727 | LSF Cemented Femoral HipJDI · Traditional | 08/09/1990SE |
| K901460 | Lsf(Tm) Total Hip SystemJDI · Traditional | 05/22/1990SN |
| K884432 | Modified LSF Total Hip SystemJDI · Traditional | 12/09/1988SE |
| K883212 | LSF (R) Total Hip System - Bipolar ComponentKXA · Traditional | 11/22/1988SE |
| K855017 | Lsf* Total Hip SystemJDI · Traditional | 06/11/1986SN |
| K841546 | Communi-Trach TubeBTO · Traditional | 04/30/1984SE |
Questions and answers
When was Implant Technology Bone Cement Extractor cleared by the FDA?
Implant Technology Bone Cement Extractor (K891472) received a 510(k) decision of Substantially Equivalent on May 2, 1989, 48 days after the submission was received.
What is the product code of K891472?
The FDA product code is LZV – System, Cement Removal Extraction, a Class II (moderate risk) device regulated under 21 CFR 888.4580.