510(k) K023594
K023594 is an FDA 510(k) premarket notification submitted by Ortheon Medical, LLC for the device "TENO FIX". The FDA issued a decision of Substantially Equivalent on May 15, 2003. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2003
- Date Received
- October 25, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type