SUMMIT MFG. AND MACHINING, INC.

FDA Device Registration & Listing · Bremen, IN, US · Registration 3004504812

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
3004504812
FEI Number
3004504812
Entity Name
SUMMIT MFG. AND MACHINING, INC.
City/State/Country
Bremen, IN, US
Establishment Address
723 High Rd, Bremen, IN 46506, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Summit Mfg. And Machining, Inc. (Owner Number: 10043195)
Owner / Operator Contact Address
P.O. Box 9, 723 High Rd., Bremen, IN 46506, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2023-03-29
HWT Template Orthopedic Class 1 888.4800 2022-01-26
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2013-01-30
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-30
HWP Punch, Femoral Neck Orthopedic Class 1 888.4540 2013-01-30
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-01-30
HXX Screwdriver Orthopedic Class 1 888.4540 2013-01-30

Official Correspondent

John Stoller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Summit Mfg. And Machining, 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 3004504812. Last updated year: 2026. Please use registration number 3004504812 when referencing this establishment in official correspondence.
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