The following data is part of a premarket notification filed by Westcon Orthopedics, Inc. with the FDA for K-cap-e, Sterile.
| Device ID | K914812 |
| 510k Number | K914812 |
| Device Name: | K-CAP-E, STERILE |
| Classification | Fixation Accessory |
| Applicant | WESTCON ORTHOPEDICS, INC. P.O. BOX 337 Three Bridges, NJ 08887 |
| Contact | Donn M Gordon |
| Correspondent | Donn M Gordon WESTCON ORTHOPEDICS, INC. P.O. BOX 337 Three Bridges, NJ 08887 |
| Product Code | LYT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-25 |
| Decision Date | 1992-01-09 |