510(k) K123668
K123668 is an FDA 510(k) premarket notification submitted by Depuy Mitek, Inc., A Johnson And Johnson Company for the device "ORTHOCORD". The FDA issued a decision of Substantially Equivalent on Feb 26, 2013. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Depuy Mitek, Inc., A Johnson And Johnson Company has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 26, 2013
- Date Received
- Nov 29, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Suture, Surgical, Absorbable, Polydioxanone
- Device Class
- Class II
- Regulation Number
- 878.4840
- Review Panel
- SU
- Submission Type
- 510(k)