FDA.reportPublic FDA data

X FIX

Primary DI
00887868083556
Brand
X FIX
Company
Biomet Orthopedics, LLC
Model
06187
Catalog number
06187
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953406000EBI X FIX DYNAFIX SYSTEM (DFS)Electro-Biology, Inc.1995-10-31KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868083556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868083556008878680835568878680835560887868083556

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692910MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692927MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692941MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692965MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002065MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08052990974535DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739536225ST.A.R. 90 F4CITIEFFE SRLKTT2019-11-29
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990972661DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974542DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974566DOLPHIXCITIEFFE SRLKTT2019-05-18
08051739531725DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531732DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531749DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531756DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531763DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531770DOLPHIXCITIEFFE SRLKTT2018-12-15