FDA.reportPublic FDA data

1.5MM SYSTEM

Primary DI
00888233001595
Brand
1.5MM SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
95-6105X
Catalog number
95-6105X
Published
2020-06-18
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
GWOPlate, cranioplasty, preformed, alterable
GXRCOVER, BURR HOLE
HBWFASTENER, PLATE, CRANIOPLASTY
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121624000
K953385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121624000BIOMET MICROFIXATION NEURO PLATING SYSTEMBiomet Microfixation2012-10-12GWO
K953385000LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEMWalter Lorenz Surgical, Inc.1995-09-28JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233001595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233001595008882330015958882330015950888233001595

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate screwA small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or congenital anomaly or disease.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810228570571CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570588CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570595CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570601FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570564CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570519CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570526FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570465FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570496FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570502FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00888118155498IPSKLS-Martin L.P.JEY2026-09-28
00888118155504IPSKLS-Martin L.P.JEY2026-09-28
00888118155511IPSKLS-Martin L.P.JEY2026-09-28
00888118155528IPSKLS-Martin L.P.JEY2026-09-28
00888118155535IPSKLS-Martin L.P.JEY2026-09-28
00888118155542IPSKLS-Martin L.P.JEY2026-09-28
00888118155559IPSKLS-Martin L.P.JEY2026-09-28
00888118155566IPSKLS-Martin L.P.JEY2026-09-28
07613327711578NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711585NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711592NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711608NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
00810228570458CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-21
00810228570373CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570380CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18