The following data is part of a premarket notification filed by Generation Ii Orthotics, Inc. with the FDA for Poli-axial Knee Cage.
| Device ID | K812064 |
| 510k Number | K812064 |
| Device Name: | POLI-AXIAL KNEE CAGE |
| Classification | Cage, Knee |
| Applicant | GENERATION II ORTHOTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITM |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-21 |
| Decision Date | 1981-08-13 |