The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Halo Support Jacket & Assoc. Hardware.
| Device ID | K792586 |
| 510k Number | K792586 |
| Device Name: | HALO SUPPORT JACKET & ASSOC. HARDWARE |
| Classification | Tong, Skull For Traction |
| Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-17 |
| Decision Date | 1979-12-31 |