The following data is part of a premarket notification filed by Orthopaedic Innovations, Inc. with the FDA for Cobra External Fixator.
| Device ID | K983881 |
| 510k Number | K983881 |
| Device Name: | COBRA EXTERNAL FIXATOR |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPAEDIC INNOVATIONS, INC. 6188 OLSON MEMORIAL HWY. Golden Valley, MN 55422 |
| Contact | Todd J Hein |
| Correspondent | Todd J Hein ORTHOPAEDIC INNOVATIONS, INC. 6188 OLSON MEMORIAL HWY. Golden Valley, MN 55422 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1998-12-04 |
| Summary: | summary |