Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2133687

FEI Number

3000206619

Entity Name

UNITY TOOL, INC.

City/State/Country

Osseo, MN, US

Establishment Address

11660 TROY LN, Osseo, MN 55369, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

UNITY TOOL, INC. (Owner Number: 9025123)

Owner / Operator Contact Address

11660 TROY LN., --, Maple Grove, MN 55369, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silhouette Max Puros Family ( Allogaft) Symmetry MAX Mergence ST360 Trinica ALP BP/Lordotic X-STOP Kyphon 28mm Reamer for Gleniod 32mm Reamer for Glenoid BP/Lordotic Sequoia (Gen ll) Pathfinder NXT Trial Eccenter Rossello Cavernotome Set Brooks Dilator Puros Family (Allogaft) Dynesys Symmetry BAC/C FlareHawk Interbody Fusion System ST360 ST360 Compressor/Distractor-STA Silhouette ST360 Manual instruments intended for spinal surgery Compressor/Distractor-LON Pangea Threaded Remobiliz Stem Holder Size 10 for Pr MIS Threaded Remobilizer Stem Holder Size 12 for Pr Stem Holder Size 6 for Pr Stem Holder Size 8 for Pr Stem Holder Size 14 for Pr Dynesys

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWB	Extractor	Orthopedic	Class 1	888.4540	2014-12-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-09-25
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2014-04-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-09-25
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2014-04-03
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-12-20
NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown	Class 3	N/A	2012-11-07
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-12-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-20
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-26
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2012-11-07
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2014-04-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-01-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-12-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-12-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-12-30
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-12-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-12-26
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-03-19

Official Correspondent

MICHAEL VAN ESSEN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UNITY TOOL, INC.

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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133687. Last updated year: 2026. Please use registration number 2133687 when referencing this establishment in official correspondence.