The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Surgical Head Support.
| Device ID | K861915 |
| 510k Number | K861915 |
| Device Name: | SURGICAL HEAD SUPPORT |
| Classification | Support, Patient Position |
| Applicant | TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Contact | Thomas Jr |
| Correspondent | Thomas Jr TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Product Code | CCX |
| CFR Regulation Number | 868.6820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-19 |
| Decision Date | 1986-05-30 |