510(k) K051764
K051764 is an FDA 510(k) premarket notification submitted by Esm Technologies for the device "T-PLATE ANTERIOR FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 13, 2005. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Esm Technologies has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 2005
- Date Received
- Jun 30, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)