510(k) DEN200035
DEN200035 is an FDA 510(k) premarket notification submitted by Miach Orthopaedics, Inc. for the device "BEAR (Bridge-Enhanced ACL Repair) Implant". The FDA issued a decision of De Novo Granted on December 16, 2020. The device falls under product code QNI (Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair), a Class II device regulated under 21 CFR 888.3044. Miach Orthopaedics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 16, 2020
- Date Received
- June 4, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- Device Class
- Class II
- Regulation Number
- 888.3044
- Review Panel
- OR
- Submission Type
A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.