OMEGA SURGICAL INSTRUMENTS, INC.

FDA Device Registration & Listing · Flint, MI, US · Registration 1834251

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
1834251
FEI Number
1000220740
Entity Name
OMEGA SURGICAL INSTRUMENTS, INC.
City/State/Country
Flint, MI, US
Establishment Address
1072 S. Elms Road, Suite E, Flint, MI 48532, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OMEGA SURGICAL INSTRUMENTS, INC. (Owner Number: 9009365)
Owner / Operator Contact Address
1072 S. Elms Road, Suite E, Flint, MI 48532, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Omega DiaMax Guide Pin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTW Bit, Drill Orthopedic Class 1 888.4540 2020-11-20
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 1994-02-01
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-02-16

Official Correspondent

Mark Burba

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OMEGA SURGICAL INSTRUMENTS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1834251. Last updated year: 2026. Please use registration number 1834251 when referencing this establishment in official correspondence.
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