Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010123303

FEI Number

3010123303

Entity Name

ProMed Concepts, LLC

City/State/Country

Brighton, TN, US

Establishment Address

7203 Hwy 14, Brighton, TN 38011, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ProMed Concepts, LLC (Owner Number: 10043266)

Owner / Operator Contact Address

7203 Hwy 14, Brighton, TN 38011, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TREPHINE IMPACTOR ORTHOPEDIC, MANUAL, SURGICAL, INSTRUMENT TAP,BONE SPINAL, VERTABRAL BODY REPLACEMENT DEVICE MALLET, SURGICAL, GENERAL AND PLASTIC SURGERY CURETTE TEMPLATE BENDER RASP RETRACTOR BLADE, SCALPEL PROBE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE SCREWDRIVER AWL REAMER STARTER, BONE SCREW KNIFE SURGICAL INSTRUMENT, SURGICAL, ORTHOPEDIC AC POWERED MOTOR AN ACCESSORY ATTACHMENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWK	Trephine	Orthopedic	Class 1	888.4540	2013-02-01
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-02-01
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-01
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-02-01
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-02-01
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-01
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-02-01
HWT	Template	Orthopedic	Class 1	888.4800	2013-02-01
HXW	Bender	Orthopedic	Class 1	888.4540	2013-02-01
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-02-01
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-02-01
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-02-01
HXB	Probe	Orthopedic	Class 1	888.4540	2013-02-01
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-02-01
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-02-01
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-02-01
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-02-01
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2013-02-01
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-01
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-02-01

Official Correspondent

Carolyn Morrison

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ProMed Concepts, 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
K041888	Signus Medizintechnik GmbH	CURVED PEEK TETRIS SPINAL IMPLANT	2004-08-10
K211892	Arftx Medical, LLC	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	2022-10-06
K070082	Vertebration,Inc	XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY	2007-04-20
K051027	Surgicraft , Ltd.	STALIF TT	2005-06-29
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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3006846753	Bradshaw Medical Inc.	Kenosha, WI, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010123303. Last updated year: 2026. Please use registration number 3010123303 when referencing this establishment in official correspondence.