LAB Medical Manufacturing, Inc.

FDA Device Registration & Listing · Billerica, MA, US · Registration 1223421

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
1223421
FEI Number
1000137655
Entity Name
LAB Medical Manufacturing, Inc.
City/State/Country
Billerica, MA, US
Establishment Address
28 Cook Street, Billerica, MA 01821, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
LAB Medical Manufacturing, Inc. (Owner Number: 10027458)
Owner / Operator Contact Address
28 Cook St., Billerica, MA 01821, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Drills and Drill Guides ORTHOPEDIC MANUAL INSTRUMENTS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2020-11-09
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2020-04-09
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-02-11
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2021-05-17

Official Correspondent

Richard Hayes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LAB Medical Manufacturing, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0040-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1223421. Last updated year: 2026. Please use registration number 1223421 when referencing this establishment in official correspondence.
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