510(k) K122487
K122487 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "BIOFIBER SYTURE". The FDA issued a decision of Substantially Equivalent on September 17, 2012. The device falls under product code NWJ (Suture, Recombinant Technology), a Class II device regulated under 21 CFR 878.4494. Tornier, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2012
- Date Received
- August 15, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Recombinant Technology
- Device Class
- Class II
- Regulation Number
- 878.4494
- Review Panel
- SU
- Submission Type
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.