FDA.reportPublic FDA data

N/A

Primary DI
00841036249601
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
PP-0444
Published
2018-05-18
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
DZJDriver, Wire, And Bone Drill, Manual
HWCScrew, Fixation, Bone
JEYPlate, Bone
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
HWCScrew, Fixation, BoneOrthopedic2
JEYPlate, BoneDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063052000
K113512000
K131674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063052000LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESWalter Lorenz Surgical, Inc.2007-01-12JEY
K113512000BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEMBiomet Microfixation2012-06-29JEY
K131674000PREBENT PLATING WITH VIRTUAL SURGICAL PLANNINGBiomet Microfixation2013-08-08JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036249601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036249601008410362496018410362496010841036249601

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
904-741-4400FXJAX-ORDERS@BIOMET.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
05420060351235TRUMATCHMaterialise NVJEY2026-10-22
05420060351235TRUMATCHMaterialise NVDZJ2026-10-22
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVDZJ2026-10-22
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVDZJ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351266TRUMATCHMaterialise NVDZJ2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVDZJ2026-10-22
05420060351280TRUMATCHMaterialise NVDZJ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVDZJ2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVDZJ2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVDZJ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVDZJ2026-10-22