MIACH ORTHOPAEDICS

FDA Device Registration & Listing · Westborough, MA, US · Registration 3020652309

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3020652309
FEI Number
3020652309
Entity Name
MIACH ORTHOPAEDICS
City/State/Country
Westborough, MA, US
Establishment Address
69 Milk Street, Suite 100, Westborough, MA 01581, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Miach Orthopaedics (Owner Number: 10082865)
Owner / Operator Contact Address
69 Milk Street, Suite 100, Westborough, MA 01581, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243578
PMA Number
N/A

All Registered Proprietary Names

BEAR® (Bridge-Enhanced ACL Repair) Implant BEAR® (Bridge-Enhanced ACL Repair) Implant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair Orthopedic Class 2 888.3044 2021-10-08
QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair Orthopedic Class 2 888.3044 2025-04-08

Official Correspondent

Gregory DeVenne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Miach Orthopaedics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020652309. Last updated year: 2026. Please use registration number 3020652309 when referencing this establishment in official correspondence.
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