The following data is part of a premarket notification filed by Depuy Ace Medical Co. with the FDA for Depuy Ace Ring Skull Pins-mri, Depuy Ace Spring Loaded Tong Pin-mri, Depuy Ace Fixed Tip Tong Pin-mri.
| Device ID | K974245 |
| 510k Number | K974245 |
| Device Name: | DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. El Segundo, CA 90245 |
| Contact | Kathleen Dragovich |
| Correspondent | Kathleen Dragovich DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. El Segundo, CA 90245 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-05-22 |
| Summary: | summary |