The following data is part of a premarket notification filed by Osteonics Reconstructive Products Div. with the FDA for Proximal Cement Spacer.
| Device ID | K895378 |
| 510k Number | K895378 |
| Device Name: | PROXIMAL CEMENT SPACER |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | OSTEONICS RECONSTRUCTIVE PRODUCTS DIV. 59 ROUTE 17 Allendale, NJ 07401 |
| Contact | Pat Kramer |
| Correspondent | Pat Kramer OSTEONICS RECONSTRUCTIVE PRODUCTS DIV. 59 ROUTE 17 Allendale, NJ 07401 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-30 |
| Decision Date | 1989-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327013641 | K895378 | 000 |
| 07613327013634 | K895378 | 000 |
| 07613327013627 | K895378 | 000 |
| 07613327013610 | K895378 | 000 |
| 07613327013603 | K895378 | 000 |
| 07613327013597 | K895378 | 000 |
| 07613327013580 | K895378 | 000 |