FDA.reportPublic FDA data

N-Force 7.3 Fixation System

Primary DI
00815612020304
Brand
N-Force 7.3 Fixation System
Company
Innovision, Inc
Model
IN027-90-FS
Catalog number
IN027-90-FS
Device description
N-Force 7.3 Fixation System 90mm Fenestrated Screw, Washer, Sheath, & Adapter Assembly
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

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
00815612020304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815612020304008156120203048156120203040815612020304

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
10886982342508VOLTSynthes GmbHHWC2026-09-25
10886982342515VOLTSynthes GmbHHWC2026-09-25
10886982342522VOLTSynthes GmbHHWC2026-09-25
10886982342539VOLTSynthes GmbHHWC2026-09-25
10886982342546VOLTSynthes GmbHHWC2026-09-25
10886982342553VOLTSynthes GmbHHWC2026-09-25
10886982342560VOLTSynthes GmbHHWC2026-09-25
10886982342577VOLTSynthes GmbHHWC2026-09-25
10886982342584VOLTSynthes GmbHHWC2026-09-25
10886982342591VOLTSynthes GmbHHWC2026-09-25