The following data is part of a premarket notification filed by Influence, Inc. with the FDA for In-tac Bone Anchor System.
| Device ID | K964953 |
| 510k Number | K964953 |
| Device Name: | IN-TAC BONE ANCHOR SYSTEM |
| Classification | Staple Driver |
| Applicant | INFLUENCE, INC. 12307 WINESAP TERRACE North Potomac, MD 20878 -2331 |
| Contact | Mark D Kramer |
| Correspondent | Mark D Kramer INFLUENCE, INC. 12307 WINESAP TERRACE North Potomac, MD 20878 -2331 |
| Product Code | HXJ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-05 |
| Decision Date | 1997-02-13 |
| Summary: | summary |