K-number	DEN200035
Device name	BEAR (Bridge-Enhanced ACL Repair) Implant
Applicant	Miach Orthopaedics, Inc.
Product code	QNI
Device class	Class II
Decision date	Dec 16, 2020
Decision	Not Substantially Equivalent
Regulation	888.3044

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Source

View the full FDA submission: accessdata.fda.gov

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BEAR (Bridge-Enhanced ACL Repair) Implant

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