The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Bone Cement Restrictor.
| Device ID | K926216 |
| 510k Number | K926216 |
| Device Name: | BONE CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| 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 | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-10 |
| Decision Date | 1994-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153768371 | K926216 | 000 |
| 04546540007957 | K926216 | 000 |
| 04546540007940 | K926216 | 000 |
| 04546540007933 | K926216 | 000 |
| 04546540007926 | K926216 | 000 |
| 04546540007919 | K926216 | 000 |
| 04546540007902 | K926216 | 000 |
| 04546540007896 | K926216 | 000 |