The following data is part of a premarket notification filed by Orthopaedic Biosystems with the FDA for Anatomic Toe System.
| Device ID | K911552 |
| 510k Number | K911552 |
| Device Name: | ANATOMIC TOE SYSTEM |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | ORTHOPAEDIC BIOSYSTEMS 701 PALOMAR AIRPORT RD. SUITE 300 Carlsbad, CA 92009 |
| Contact | Randall Huebner |
| Correspondent | Randall Huebner ORTHOPAEDIC BIOSYSTEMS 701 PALOMAR AIRPORT RD. SUITE 300 Carlsbad, CA 92009 |
| Product Code | LZJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1991-06-28 |