510(k) K101375
K101375 is an FDA 510(k) premarket notification submitted by TriMed, Inc. for the device "TRIMED X-FIX". The FDA issued a decision of Substantially Equivalent on September 15, 2010. The device falls under product code NDK (System, External Fixator (With Metallic Invasive Components)), a Class II device regulated under 21 CFR 888.3040. TriMed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2010
- Date Received
- May 17, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, External Fixator (With Metallic Invasive Components)
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type