FDA.reportPublic FDA data

N-Force 7.3 Fixation System

Primary DI
00815612020250
Brand
N-Force 7.3 Fixation System
Company
Innovision, Inc
Model
IN027-65-FS
Catalog number
IN027-65-FS
Device description
N-Force 7.3 Fixation System 65mm 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
00815612020250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815612020250008156120202508156120202500815612020250

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)348-2775contactus@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
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01