The following data is part of a premarket notification filed by Bodycad Laboratories, Inc. with the FDA for Fine Osteotomy Around The Knee.
| Device ID | K193614 |
| 510k Number | K193614 |
| Device Name: | FINE Osteotomy Around The Knee |
| Classification | Plate, Fixation, Bone |
| Applicant | Bodycad Laboratories, Inc. 2035, Rue Du Haut-Bord Quebec City, CA G1n 4r7 |
| Contact | Guy Sevigny |
| Correspondent | Robert A Poggie BioVera Inc. 65 Promenade Saint Louis Notre-dame-del-l'ile-perrot, CA J7v 7p2 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | PBF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00688346000559 | K193614 | 000 |
| 00688346000405 | K193614 | 000 |
| 00688346000399 | K193614 | 000 |
| 00688346000382 | K193614 | 000 |
| 00688346000375 | K193614 | 000 |
| 00688346000368 | K193614 | 000 |
| 00688346000351 | K193614 | 000 |
| 00688346000344 | K193614 | 000 |
| 00688346000337 | K193614 | 000 |
| 00688346000320 | K193614 | 000 |
| 00688346000290 | K193614 | 000 |
| 00688346000283 | K193614 | 000 |
| 00688346000122 | K193614 | 000 |
| 00688346000108 | K193614 | 000 |
| 00688346000078 | K193614 | 000 |
| 00688346000412 | K193614 | 000 |
| 00688346000429 | K193614 | 000 |
| 00688346000542 | K193614 | 000 |
| 00688346000535 | K193614 | 000 |
| 00688346000528 | K193614 | 000 |
| 00688346000139 | K193614 | 000 |
| 00688346000115 | K193614 | 000 |
| 00688346000511 | K193614 | 000 |
| 00688346000504 | K193614 | 000 |
| 00688346000498 | K193614 | 000 |
| 00688346000481 | K193614 | 000 |
| 00688346000474 | K193614 | 000 |
| 00688346000467 | K193614 | 000 |
| 00688346000450 | K193614 | 000 |
| 00688346000443 | K193614 | 000 |
| 00688346000436 | K193614 | 000 |
| 00688346000047 | K193614 | 000 |