OSTEOFIT LLC

FDA Device Registration & Listing · Fairfield, NJ, US · Registration 3023028944

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
3023028944
FEI Number
3023028944
Entity Name
OSTEOFIT LLC
City/State/Country
Fairfield, NJ, US
Establishment Address
24 Sherwood Lane, Fairfield, NJ 07004, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OsteoFit LLC (Owner Number: 10085439)
Owner / Operator Contact Address
24 Sherwood Lane, Fairfield, NJ 07004, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OsteoFit Single-Use Acetabular Reamer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2022-06-17

Official Correspondent

Jaclyn Docs

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OsteoFit LLC
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 3023028944. Last updated year: 2026. Please use registration number 3023028944 when referencing this establishment in official correspondence.
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