The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Bone Screw Tacking Kit.
| Device ID | K951510 |
| 510k Number | K951510 |
| Device Name: | ACE BONE SCREW TACKING KIT |
| Classification | Screw, Fixation, Intraosseous |
| 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 | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950030675 | K951510 | 000 |
| 00614950030668 | K951510 | 000 |
| 00614950030101 | K951510 | 000 |