510(k) K964953
K964953 is an FDA 510(k) premarket notification submitted by Influence, Inc. for the device "IN-TAC BONE ANCHOR SYSTEM". The FDA issued a decision of Substantially Equivalent on February 13, 1997. The device falls under product code HXJ (Staple Driver), a Class I device regulated under 21 CFR 888.4540. Influence, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1997
- Date Received
- December 5, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple Driver
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type