BEAR (Bridge-Enhanced ACL Repair) Implant— 510(k) DEN200035

Name: FDA 510(k) clearance DEN200035
Creator: U.S. Food and Drug Administration
Published: 2020-12-16

Unknown

Miach Orthopaedics, Inc.

FDA 510(k) clearance DEN200035 for BEAR (Bridge-Enhanced ACL Repair) Implant, Unknown on 2020-12-16. Applicant: Miach Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Miach Orthopaedics, Inc.
Product code: Code QNI
Device class: Class 2
Regulation: 21 CFR 888.3044
Advisory panel: Orthopedic
Date received: 2020-06-04
Decision date: 2020-12-16
Decision: Unknown
Clearance type: Direct
Location: Westborough, MA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.