FDA.reportPublic FDA data

N-Force 4.0 Fixation System

Primary DI
00815612020236
Brand
N-Force 4.0 Fixation System
Company
Innovision, Inc
Model
IN043-1
Catalog number
IN043-1
Device description
N-Force 4.0 Fixation System Inset Washer
Published
2016-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132244000
K151146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132244000N-FORCE FIXATION SYSTEMInnovision, Inc.2014-03-06HWC
K151146000N-Force Fixation SystemInnovision, Inc.2015-07-24HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815612020236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815612020236008156120202368156120202360815612020236

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, sterileA sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)348-2759contactus@zimmberbiomet.com

Regulatory Flags#

DUNS number
942243767
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815612020007N-Force 4.0 Fixation System IN001-25-FSIN001-25-FS2016-02-05
00815612020014N-Force 4.0 Fixation SystemIN001-30-FSIN001-30-FS2016-02-05
00815612020021N-Force 4.0 Fixation SystemIN001-35-FSIN001-35-FS2016-02-05
00815612020038N-Force 4.0 Fixation System IN001-40-FSIN001-40-FS2016-02-05
00815612020045N-Force 4.0 Fixation SystemIN001-45-FSIN001-45-FS2016-02-05
00815612020052N-Force 4.0 Fixation SystemIN001-50-FSIN001-50-FS2016-02-05
00815612020069N-Force 4.0 Fixation SystemIN001-55-FSIN001-55-FS2016-02-05
00815612020076N-Force 4.0 Fixation System IN001-60-FSIN001-60-FS2016-02-05
00815612020083N-Force 4.0 Fixation SystemIN001-65-FSIN001-65-FS2016-02-05
00815612020090N-Force 4.0 Fixation SystemIN001-70-FSIN001-70-FS2016-02-05
00815612020106N-Force 4.0 Fixation SystemIN001-75-FSIN001-75-FS2016-02-05
00815612020113N-Force 4.0 Fixation SystemIN006-75-FSIN006-75-FS2016-02-05
00815612020120N-Force 4.0 Fixation SystemIN006-70-FSIN006-70-FS2016-02-05
00815612020137N-Force 4.0 Fixation SystemIN006-65-FSIN006-65-FS2016-02-05
00815612020144N-Force 4.0 Fixation SystemIN006-60-FSIN006-60-FS2016-02-05
00815612020151N-Force 4.0 Fixation SystemIN006-55-FSIN006-55-FS2016-02-05
00815612020168N-Force 4.0 Fixation SystemIN006-50-FSIN006-50-FS2016-02-05
00815612020175N-Force 4.0 Fixation SystemIN006-45-FSIN006-45-FS2016-02-05
00815612020182N-Force 4.0 Fixation SystemIN006-40-FSIN006-40-FS2016-02-05
00815612020199N-Force 4.0 Fixation SystemIN006-35-FSIN006-35-FS2016-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
07613327075830ASNISStryker GmbHHTN2015-11-11
07613327076189ASNISStryker GmbHHTN2015-11-11
07613327076301ASNISStryker GmbHHTN2015-11-11
07613327076554ASNISStryker GmbHHTN2015-11-11
07613327076721ASNISStryker GmbHHTN2015-11-11
07613327076929ASNISStryker GmbHHTN2015-11-11
07613327077049ASNISStryker GmbHHTN2015-11-11
07613327073737VARIAXStryker GmbHHTN2015-09-30
07613327073768VARIAXStryker GmbHHTN2015-09-30
07613327073799VARIAXStryker GmbHHTN2015-09-30
07613327073812VARIAXStryker GmbHHTN2015-09-30