FDA.reportPublic FDA data

SIGNATURE

Primary DI
00880304516328
Brand
SIGNATURE
Company
Biomet Orthopedics, LLC
Model
42-100104
Catalog number
42-100104
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111863000SIGNATURE PLANNER,SIGNATURE GUIDESMaterialise NV2012-06-15JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304516328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304516328008803045163288803045163280880304516328

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370456CEMENT NOZZLE4149914149912017-07-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713512G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713512G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03