Tenodesis Cross Screw, Interference Screw, Suture Bead
FDA 510(k) K081348 · TriMed, Inc.
510(k) numberK081348
Submission
- Device name
- Tenodesis Cross Screw, Interference Screw, Suture Bead
- Applicant
- TriMed, Inc.
Valencia, CA, US - Received
- May 14, 2008
- Decision date
- October 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Tenodesis Cross Screw, Interference Screw, Suture Bead cleared by the FDA?
Tenodesis Cross Screw, Interference Screw, Suture Bead (K081348) received a 510(k) decision of Substantially Equivalent on October 17, 2008, 156 days after the submission was received.
What is the product code of K081348?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.