510(k) K052572
K052572 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH KNOTLESS ANCHOR". The FDA issued a decision of Substantially Equivalent on December 5, 2005. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2005
- Date Received
- September 19, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type