FDA.reportPublic FDA data

N-Force 4.0 Fixation System

Primary DI
00815612020229
Brand
N-Force 4.0 Fixation System
Company
Innovision, Inc
Model
IN048-FS
Catalog number
IN048-FS
Device description
N-Force 4.0 Fixation System Sheath & 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
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

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
00815612020229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815612020229008156120202298156120202290815612020229

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. 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

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Primary DI, Brand, Company table
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