The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for The Universal Bone Cement Resistor.
| Device ID | K924323 |
| 510k Number | K924323 |
| Device Name: | THE UNIVERSAL BONE CEMENT RESISTOR |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Contact | Andrew E Taylor |
| Correspondent | Andrew E Taylor BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1993-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153768333 | K924323 | 000 |
| 07613153768258 | K924323 | 000 |
| 07613153768210 | K924323 | 000 |
| 07613153768111 | K924323 | 000 |
| 04546540007889 | K924323 | 000 |
| 04546540000279 | K924323 | 000 |