The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Miniboneplate System.
| Device ID | K951392 |
| 510k Number | K951392 |
| Device Name: | MINIBONEPLATE SYSTEM |
| Classification | Plate, Bone |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Contact | J. E Carchidi |
| Correspondent | J. E Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-21 |
| Decision Date | 1995-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950008094 | K951392 | 000 |
| 00614950005956 | K951392 | 000 |
| 10614950005946 | K951392 | 000 |
| 10614950005939 | K951392 | 000 |
| 10614950005922 | K951392 | 000 |
| 10614950005915 | K951392 | 000 |
| 10614950005908 | K951392 | 000 |
| 10614950005892 | K951392 | 000 |
| 10614950005885 | K951392 | 000 |
| 10614950005878 | K951392 | 000 |
| 10614950005861 | K951392 | 000 |
| 10614950005854 | K951392 | 000 |
| 00614950005567 | K951392 | 000 |
| 00614950000210 | K951392 | 000 |
| 00614950000203 | K951392 | 000 |
| 00614950000197 | K951392 | 000 |
| 00614950005963 | K951392 | 000 |
| 00614950005970 | K951392 | 000 |
| 10614950007070 | K951392 | 000 |
| 10614950007063 | K951392 | 000 |
| 00614950006328 | K951392 | 000 |
| 00614950006311 | K951392 | 000 |
| 00614950006304 | K951392 | 000 |
| 00614950006298 | K951392 | 000 |
| 00614950006281 | K951392 | 000 |
| 00614950006175 | K951392 | 000 |
| 00614950006090 | K951392 | 000 |
| 00614950006083 | K951392 | 000 |
| 00614950006076 | K951392 | 000 |
| 00614950006014 | K951392 | 000 |
| 00614950006007 | K951392 | 000 |
| 00614950005994 | K951392 | 000 |
| 00614950005987 | K951392 | 000 |
| 00614950000180 | K951392 | 000 |