The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Oxford External Fixation System.
| Device ID | K800184 |
| 510k Number | K800184 |
| Device Name: | OXFORD EXTERNAL FIXATION SYSTEM |
| Classification | Component, Traction, Invasive |
| Applicant | DOWNS SURGICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-29 |
| Decision Date | 1980-02-11 |