The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Open-back Halo Ring.
| Device ID | K914858 |
| 510k Number | K914858 |
| Device Name: | ACE OPEN-BACK HALO RING |
| Classification | Component, Traction, Invasive |
| Applicant | ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Contact | Claude O Pering |
| Correspondent | Claude O Pering ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1991-11-21 |