FDA.reportPublic FDA data

1.5 LACTOSORB SYSTEM

Primary DI
00841036055189
Brand
1.5 LACTOSORB SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
915-2315
Catalog number
915-2315
Published
2015-10-11
Public version status
Update
Distribution status
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
HRSPLATE, FIXATION, BONE
HWCScrew, fixation, bone
NHBPOLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
NHBPolymer, Ear, Nose And Throat, Synthetic, AbsorbableEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012409000
K955729000
K971870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012409000LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTSWalter Lorenz Surgical, Inc.2001-10-18NHB
K955729000LACTOSORB TRAUMA PLATING SYSTEMPoly-Medics,Inc.1996-02-14HRS
K971870000LACTOSORB TRAUMA PLATING SYSTEMBiomet, Inc.1997-08-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036055189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036055189008410360551898410360551890841036055189

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.

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
00888867627840Arthrex®ARTHREX, INC.HWC2026-10-07
00888867627857Arthrex®ARTHREX, INC.HWC2026-10-07
00888867627864Arthrex®ARTHREX, INC.HWC2026-10-07
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
10806378125997ACUMEDAcumed LLCHWC2025-12-08
10806378126000ACUMEDAcumed LLCHWC2025-12-08
10806378126017ACUMEDAcumed LLCHWC2025-12-08
10806378126024ACUMEDAcumed LLCHWC2025-12-08
10806378126031ACUMEDAcumed LLCHWC2025-12-08
10806378126048ACUMEDAcumed LLCHWC2025-12-08
10806378126055ACUMEDAcumed LLCHWC2025-12-08
10806378126062ACUMEDAcumed LLCHWC2025-12-08
10806378126079ACUMEDAcumed LLCHWC2025-12-08
10806378126086ACUMEDAcumed LLCHWC2025-12-08
10806378126093ACUMEDAcumed LLCHWC2025-12-08
10806378126109ACUMEDAcumed LLCHWC2025-12-08
10806378126116ACUMEDAcumed LLCHWC2025-12-08