Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010622588

FEI Number

3010622588

Entity Name

ARCAMED, LLC

City/State/Country

Indianapolis, IN, US

Establishment Address

5101 Decatur Blvd, Suite A, Indianapolis, IN 46241, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Arcamed, LLC (Owner Number: 10045595)

Owner / Operator Contact Address

5101 Decatur Blvd., Ste. A, Indianapolis, IN 46241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2026-05-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-05-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-05-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-05-19
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-12-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-12-05

Official Correspondent

Brandon Sobera

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arcamed, LLC

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
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

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3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3003604053	SMITH & NEPHEW INC.	ANDOVER, MA, US
3008870565	Implant Logistics / AMS Micromedical	Sparta, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010622588. Last updated year: 2026. Please use registration number 3010622588 when referencing this establishment in official correspondence.