510(k) K203393
K203393 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "FAST-FIX FLEX". The FDA issued a decision of Substantially Equivalent on Feb 1, 2021. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 2021
- Date Received
- Nov 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type
- 510(k)