510(k) K243578
- Device
- BEAR® (Bridge-Enhanced ACL Restoration) Implant
- Applicant
- Miach Orthopaedics, Inc.
- 510(k) number
- K243578
- Product code
- QNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-06
- Date received
- 2024-11-19
- Regulation
- 888.3044
- Classification name
- Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Rita Paparazzo
- Address
- 69 Milk St., Suite 100 Westborough MA US 01581 01581
FDA Registration Numbers#
- 3013820501
- 3020652309
- 2530154