510(k) DEN200035
- Device
- BEAR (Bridge-Enhanced ACL Repair) Implant
- Applicant
- Miach Orthopaedics, Inc.
- 510(k) number
- DEN200035
- Product code
- QNI
- Decision
- Unknown (DENG)
- Decision date
- 2020-12-16
- Date received
- 2020-06-04
- Regulation
- 888.3044
- Classification name
- Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Martha Shadan
- Address
- 69 Milk St., Suite 100 Westborough MA US 01581 01581
FDA Registration Numbers#
- 3013820501
- 3020652309
- 2530154
Source Documents#
510(k) summary PDF not indicated by FDA