FDA.reportPublic FDA data

1.5 LACTOSORB SYSTEM

Primary DI
00841036054908
Brand
1.5 LACTOSORB SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
915-2219
Catalog number
915-2219
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
NHBPOLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHBPolymer, Ear, Nose And Throat, Synthetic, AbsorbableEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012409000LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTSWalter Lorenz Surgical, Inc.2001-10-18NHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036054908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036054908008410360549088410360549080841036054908

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
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860011696315SeptAlignSPIRAIR, INC.NHB2024-10-16
00801741044083HEMADERMDavol Inc.NHB2023-10-09
10801741044080HemaDermDavol Inc.NHB2023-10-09
00860001820898PuraGel 5mL3-D MATRIX INC.NHB2023-09-20
00860007400308PuraGel 3mL3-D MATRIX INC.NHB2023-09-20
00860007400315PuraGel 1mL3-D MATRIX INC.NHB2023-09-20
00860001820829PuraSinus 5mL3-D MATRIX INC.NHB2022-07-13
00860001820836PuraSinus 3mL3-D MATRIX INC.NHB2022-07-13
00860001820843PuraSinus 1mL3-D MATRIX INC.NHB2022-07-13
00857037006075LATERASTRYKER CORPORATIONNHB2020-01-14
00857037006013LATERASTRYKER CORPORATIONNHB2020-01-08
00857037006037LATERASTRYKER CORPORATIONNHB2020-01-08
00857037006082LATERASTRYKER CORPORATIONNHB2018-06-04
00857037006105LATERASTRYKER CORPORATIONNHB2017-09-19
00857037006921LATERAENTELLUS MEDICAL, INC.NHB2017-09-19
10705031087965PDS PlatesEthicon Inc.NHB2017-06-15
10705031087989PDS PlatesEthicon Inc.NHB2017-06-15
20705031087962PDS PlatesEthicon Inc.NHB2017-06-15
20705031087986PDS PlatesEthicon Inc.NHB2017-06-15
10705031087934PDS PlatesEthicon Inc.NHB2017-06-14
10705031087941PDS PlatesEthicon Inc.NHB2017-06-14
10705031087958PDS PlatesEthicon Inc.NHB2017-06-14
10705031087972PDS PlatesEthicon Inc.NHB2017-06-14
10705031087996PDS PlatesEthicon Inc.NHB2017-06-14
10705031088009PDS PlatesEthicon Inc.NHB2017-06-14
10705031132511PDS PlatesEthicon Inc.NHB2017-06-14
10705031132528PDS PlatesEthicon Inc.NHB2017-06-14
10705031132535PDS PlatesEthicon Inc.NHB2017-06-14
20705031087931PDS PlatesETHICON INC.NHB2017-06-14