Questus Polyester Suture Soft Tissue Anchor System
FDA 510(k) K963200 · Wrightmedicaltechnologyinc
510(k) numberK963200
Submission
- Device name
- Questus Polyester Suture Soft Tissue Anchor System
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- August 15, 1996
- Decision date
- October 2, 1996
- 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 Questus Polyester Suture Soft Tissue Anchor System cleared by the FDA?
Questus Polyester Suture Soft Tissue Anchor System (K963200) received a 510(k) decision of Substantially Equivalent on October 2, 1996, 48 days after the submission was received.
What is the product code of K963200?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.