FDA.reportPublic FDA data

2.0 LactoSorb System

Primary DI
00888233025256
Brand
2.0 LactoSorb System
Company
BIOMET MICROFIXATION, INC
Model
915-2308-EA
Catalog number
915-2308-EA
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
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992355000LACTOSORB TRAUMA PLATING SYSTEMBiomet, Inc.1999-12-20HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233025256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233025256008882330252568882330252560888233025256

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
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036020811Mimix QS02-11052015-09-11
00841036020828Mimix QS02-11102015-09-11
00841036020965MIMIX02-20052015-09-11
00841036020996MIMIX02-20102015-09-11
00841036021009MIMIX02-20252015-09-11
00841036141943OTOMIMIX7014-32662015-09-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731132642REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132659REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132666REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132673REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132680REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132697REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132703REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132710REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132727REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132734REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132741REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132758REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132765REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132772REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132789REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132796REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132802REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132819REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132826REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132833REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132840REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132857REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132864REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132871REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132888REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132895REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132901REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132918REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132925REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132932REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03