The following data is part of a premarket notification filed by Blue Belt Technologies, Inc. with the FDA for Stride Unicondylar Knee.
| Device ID | K123380 |
| 510k Number | K123380 |
| Device Name: | STRIDE UNICONDYLAR KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | BLUE BELT TECHNOLOGIES, INC. 2828 LIBERTY AVENUE SUITE 100 Pittsburgh, PA 15222 |
| Contact | Rick Confer |
| Correspondent | Rick Confer BLUE BELT TECHNOLOGIES, INC. 2828 LIBERTY AVENUE SUITE 100 Pittsburgh, PA 15222 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-01 |
| Decision Date | 2013-05-31 |
| Summary: | summary |