Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014019090

FEI Number

3014019090

Entity Name

BLUSTONE SYNERGY, LLC

City/State/Country

Pueblo, CO, US

Establishment Address

5520 Ventana Ct, Pueblo, CO 81005, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Blustone Synergy, LLC (Owner Number: 10055810)

Owner / Operator Contact Address

5520 Ventana Ct., Pueblo, CO 81005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blustone Synergy Slate Parallel Cervical Rasp Blustone Synergy Slate Lordotic Cervical Rasp Blustone Synergy Baalt Lumbar PLIF Pusher Blustone Synergy Obsidian Lumbar TLIF Pusher Blustone Synergy Silica Corpectomy/Slate Cervical Pusher Blustone Synergy Silica Corpectomy System Blustone Synergy Slate Parallel Cervical Trial Blustone Synergy Basalt/Obsidian/Magma Lumbar Trial/Spreader Blustone Synergy Slate Lordotic Cervical Trial Blustone Synergy Obsidian Lumbar Interbody Fusion System Blustone Synergy Basalt Lumbar Interbody Fusion System Blustone Synergy Magma Lumbar Interbody Fusion System Blustone Synergy Slate Cervical Interbody Fusion System Blustone Synergy Basalt/Magma/Obsidian Lumbar Shaver

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2017-12-22
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2017-12-22
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-12-21
HWT	Template	Orthopedic	Class 1	888.4800	2017-12-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-10-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-10-09
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2017-12-22

Official Correspondent

Tom Gentry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Blustone Synergy, 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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04

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2431166	Sklar Corporation	West Chester, PA, US
3000931034	Tornier S.A.S.	Montbonnot Saint-Martin Isere, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014019090. Last updated year: 2026. Please use registration number 3014019090 when referencing this establishment in official correspondence.