510(k) K090128
K090128 is an FDA 510(k) premarket notification submitted by Core Essence Orthopaedics, Inc. for the device "TAC-TITE (TM)". The FDA issued a decision of Substantially Equivalent on March 19, 2009. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Core Essence Orthopaedics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2009
- Date Received
- January 21, 2009
- Clearance Type
- Special
- 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