Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011567699

FEI Number

3011567699

Entity Name

ARC PRECISION

City/State/Country

Isanti, MN, US

Establishment Address

24726 Ulysses Ct NE, Isanti, MN 55040, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Arc Precision (Owner Number: 10048923)

Owner / Operator Contact Address

24726 Ulysses Ct. NE, Isanti, MN 55040, US

Initial Importer Flag

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
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-11-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-03-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-03-19
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-11-25
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2024-11-25

Official Correspondent

Jeffrey Bell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arc Precision

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Similar Registrations

Registration Number	Establishment Name	Location
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
3038187464	MIRACLUS ORTHOTECH PRIVATE LIMITED	Ahmedabad Gujarat, IN
3011513267	FLOSPINE LLC	Boca Raton, FL, US
3003882387	B. ALI IMPEX	SIALKOT, Punjab, PK
3008021110	Limacorporate S.p.A.	Villanova di San Daniele Udine, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011567699. Last updated year: 2026. Please use registration number 3011567699 when referencing this establishment in official correspondence.