510(k) K891472
- Device
- IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
- Applicant
- IMPLANT TECHNOLOGY, INC.
- 510(k) number
- K891472
- Product code
- LZV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-02
- Date received
- 1989-03-15
- Regulation
- 888.4580
- Classification name
- System, Cement Removal Extraction
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER J SCRANTON
- Address
- 400 Plz. Dr. Secaucus NJ US 07094 07094
FDA Registration Numbers#
- 3012663306
- 3036690185
- 2025102
- 2183449
- 9680825
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021502 | OSCAR, MODEL OE3000 | Orthosonics, Ltd. | 2002-06-06 |
| 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 |
| K890285 | PROSTHETIC CEMENT REMOVER | Albert K. Chin | 1989-04-19 |
Legacy Summary#
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FDA Review#
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