510(k) K011172
K011172 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "ARTHREX BIO-TRANSFIX". The FDA issued a decision of Substantially Equivalent on June 19, 2001. The device falls under product code MNU (Staple, Absorbable), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2001
- Date Received
- April 17, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Absorbable
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type