The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Endo Link Intracondylar Rotating.
| Device ID | K821476 |
| 510k Number | K821476 |
| Device Name: | BARD ENDO LINK INTRACONDYLAR ROTATING |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-18 |
| Decision Date | 1982-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575253647 | K821476 | 000 |
| 04026575400126 | K821476 | 000 |
| 04026575400133 | K821476 | 000 |
| 04026575992904 | K821476 | 000 |
| 04026575992911 | K821476 | 000 |
| 04026575992928 | K821476 | 000 |
| 04026575992935 | K821476 | 000 |
| 04026575992942 | K821476 | 000 |
| 04026575992973 | K821476 | 000 |
| 04026575253623 | K821476 | 000 |
| 04026575253630 | K821476 | 000 |
| 04026575400119 | K821476 | 000 |