The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Surigical Tru-fix Implant System, Model 454-180x-xx.
| Device ID | K080074 |
| 510k Number | K080074 |
| Device Name: | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | J. Edward Carchidi |
| Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-11 |
| Decision Date | 2008-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950006274 | K080074 | 000 |
| 10614950006134 | K080074 | 000 |
| 10614950006127 | K080074 | 000 |
| 10614950006110 | K080074 | 000 |
| 10614950006103 | K080074 | 000 |
| 10614950006066 | K080074 | 000 |
| 10614950006059 | K080074 | 000 |
| 10614950006042 | K080074 | 000 |
| 10614950006035 | K080074 | 000 |
| 10614950006028 | K080074 | 000 |
| 00614950031436 | K080074 | 000 |
| 10614950006141 | K080074 | 000 |
| 10614950006158 | K080074 | 000 |
| 00614950006267 | K080074 | 000 |
| 00614950006250 | K080074 | 000 |
| 10614950006240 | K080074 | 000 |
| 10614950006233 | K080074 | 000 |
| 10614950006226 | K080074 | 000 |
| 10614950006219 | K080074 | 000 |
| 10614950006202 | K080074 | 000 |
| 10614950006196 | K080074 | 000 |
| 10614950006189 | K080074 | 000 |
| 10614950006165 | K080074 | 000 |
| 00614950031429 | K080074 | 000 |