FDA.reportPublic FDA data

Versa-Fx®

Primary DI
00889024035720
Brand
Versa-Fx®
Company
Zimmer, Inc.
Model
1193-05-45
Catalog number
00-1193-005-45
Published
2015-09-24
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150818000Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation SystemZimmer, Inc.2015-05-01KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024035720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024035720008890240357208890240357200889024035720

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length105Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10
00889024701465Identity® Shoulder System11007751110077512026-06-10
00889024701472Identity® Shoulder System11007752110077522026-06-10

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Primary DI, Brand, Company table
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00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
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00810068850321Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
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00810068850635Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850642Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
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00810068850710Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850727Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850734Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850741Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850758Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850772Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
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