FDA.reportPublic FDA data

LACTOSORB SYSTEM

Primary DI
00841036159436
Brand
LACTOSORB SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
SP-1690
Catalog number
SP-1690
Published
2015-10-11
Public version status
Update
Distribution status
Not 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
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030425000LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDERWalter Lorenz Surgical, Inc.2004-05-14JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036159436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036159436008410361594368410361594360841036159436

GMDN Terms#

Term, Definition table
TermDefinition
Implantable craniofacial bone distractorAn implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Expiration date on label
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
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351334TRUMATCHMaterialise NVJEY2026-10-22
05420060351341TRUMATCHMaterialise NVJEY2026-10-22
05420060351358TRUMATCHMaterialise NVJEY2026-10-22
05420060351365TRUMATCHMaterialise NVJEY2026-10-22
05420060351372TRUMATCHMaterialise NVJEY2026-10-22
05420060351389TRUMATCHMaterialise NVJEY2026-10-22
05420060351396TRUMATCHMaterialise NVJEY2026-10-22
05420060351402TRUMATCHMaterialise NVJEY2026-10-22
00888118150288LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150295LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150301LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150318LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150325LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150332LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150349LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150356LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150363LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150370LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150387LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150394LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21