510(k) K103248
K103248 is an FDA 510(k) premarket notification submitted by Integra Life Sciences for the device "INTEGRITY SPINAL CARE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 5, 2011. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Integra Life Sciences has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2011
- Date Received
- November 3, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type