The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Pt Ii Distal Cement Spacer.
| Device ID | K914406 |
| 510k Number | K914406 |
| Device Name: | PT II DISTAL CEMENT SPACER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch |
| Correspondent | Robert A Koch OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-02 |
| Decision Date | 1991-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327013986 | K914406 | 000 |
| 07613327013818 | K914406 | 000 |
| 07613327013825 | K914406 | 000 |
| 07613327013832 | K914406 | 000 |
| 07613327013849 | K914406 | 000 |
| 07613327013856 | K914406 | 000 |
| 07613327013863 | K914406 | 000 |
| 07613327013870 | K914406 | 000 |
| 07613327013894 | K914406 | 000 |
| 07613327013900 | K914406 | 000 |
| 07613327013917 | K914406 | 000 |
| 07613327013924 | K914406 | 000 |
| 07613327013931 | K914406 | 000 |
| 07613327013948 | K914406 | 000 |
| 07613327013955 | K914406 | 000 |
| 07613327013962 | K914406 | 000 |
| 07613327013979 | K914406 | 000 |
| 07613327013801 | K914406 | 000 |