The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Humerus & Radius Plates.
| Device ID | K955472 |
| 510k Number | K955472 |
| Device Name: | ACE HUMERUS & RADIUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-30 |
| Decision Date | 1996-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868022784 | K955472 | 000 |
| 00887868022623 | K955472 | 000 |
| 00887868022616 | K955472 | 000 |
| 00887868001109 | K955472 | 000 |
| 00887868001093 | K955472 | 000 |
| 00887868001086 | K955472 | 000 |
| 00887868001062 | K955472 | 000 |
| 00887868001055 | K955472 | 000 |
| 00887868001048 | K955472 | 000 |
| 00887868001031 | K955472 | 000 |
| 00887868001024 | K955472 | 000 |
| 00887868001000 | K955472 | 000 |
| 00887868000997 | K955472 | 000 |
| 00887868022630 | K955472 | 000 |
| 00887868022647 | K955472 | 000 |
| 00887868022654 | K955472 | 000 |
| 00887868022777 | K955472 | 000 |
| 00887868022760 | K955472 | 000 |
| 00887868022753 | K955472 | 000 |
| 00887868022746 | K955472 | 000 |
| 00887868022739 | K955472 | 000 |
| 00887868022722 | K955472 | 000 |
| 00887868022715 | K955472 | 000 |
| 00887868022708 | K955472 | 000 |
| 00887868022692 | K955472 | 000 |
| 00887868022685 | K955472 | 000 |
| 00887868022678 | K955472 | 000 |
| 00887868022661 | K955472 | 000 |
| 00887868000980 | K955472 | 000 |