Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006215390

FEI Number

3006215390

Entity Name

Unified Spine, LLC

City/State/Country

Westerville, OH, US

Establishment Address

6295 Maxtown Road, Suite #500, Westerville, OH 43082, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Unified Spine, LLC (Owner Number: 10083837)

Owner / Operator Contact Address

6295 Maxtown Road, Suite #500, Westerville, OH 43082, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GSO GS1 Cannulated Screw System GSO ACP1 Anterior Cervical Plate System Gso Gs1 Spacer Gso GS1 Spinal System GSO PCT Spinal System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-12-22
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2021-12-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-12-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2021-12-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2021-12-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-12-22
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2021-12-22
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2021-12-22
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-12-22
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2021-12-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2021-12-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2021-12-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-12-22
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-12-22
KTZ	Caliper	Orthopedic	Class 1	888.4150	2021-12-22
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-12-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-12-22
HXB	Probe	Orthopedic	Class 1	888.4540	2021-12-22

Official Correspondent

Scott Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Unified Spine, 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
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number	Establishment Name	Location
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US
2027467	ALPHATEC SPINE, INC.	Carlsbad, CA, US
9612420	ULRICH GMBH & CO. KG	ULM Baden-Wurttemberg, DE
3036756245	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Perai Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006215390. Last updated year: 2026. Please use registration number 3006215390 when referencing this establishment in official correspondence.