The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Surgical Secure Locator 3.25 Implant System.
| Device ID | K093518 |
| 510k Number | K093518 |
| Device Name: | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM |
| 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 | 2009-11-13 |
| Decision Date | 2010-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950003563 | K093518 | 000 |
| 00614950003037 | K093518 | 000 |
| 00614950003020 | K093518 | 000 |
| 00614950003013 | K093518 | 000 |
| 00614950003006 | K093518 | 000 |
| 00614950002993 | K093518 | 000 |
| 00614950002986 | K093518 | 000 |
| 00614950002979 | K093518 | 000 |
| 00614950002962 | K093518 | 000 |
| 00614950002955 | K093518 | 000 |
| 00614950002948 | K093518 | 000 |
| 00614950002931 | K093518 | 000 |
| 00614950003426 | K093518 | 000 |
| 00614950003433 | K093518 | 000 |
| 00614950003440 | K093518 | 000 |
| 00614950003556 | K093518 | 000 |
| 00614950003549 | K093518 | 000 |
| 00614950003532 | K093518 | 000 |
| 00614950003525 | K093518 | 000 |
| 00614950003518 | K093518 | 000 |
| 00614950003501 | K093518 | 000 |
| 00614950003495 | K093518 | 000 |
| 00614950003488 | K093518 | 000 |
| 00614950003471 | K093518 | 000 |
| 00614950003464 | K093518 | 000 |
| 00614950003457 | K093518 | 000 |
| 00614950002924 | K093518 | 000 |