Trellis Collagen Ribbon
FDA 510(k) K131143 · Wrightmedicaltechnologyinc
510(k) numberK131143
Submission
- Device name
- Trellis Collagen Ribbon
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- April 23, 2013
- Decision date
- October 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in tendon repair.
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Questions and answers
When was Trellis Collagen Ribbon cleared by the FDA?
Trellis Collagen Ribbon (K131143) received a 510(k) decision of Substantially Equivalent on October 7, 2013, 167 days after the submission was received.
What is the product code of K131143?
The FDA product code is OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.