FDA.reportPublic FDA data

2.0 LACTOSORB SYSTEM

Primary DI
00841036054380
Brand
2.0 LACTOSORB SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
915-2100
Catalog number
915-2100
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955729000
K971870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
00841036054380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036054380008410360543808410360543800841036054380

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, 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 is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). 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

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWC2026-07-10
00190446944331Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446944348Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952213Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952220Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952237Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952244Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952251Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952268Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952275Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952282Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952299Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952305Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952312Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952329Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25