FDA.reportPublic FDA data

MAX-TI

Primary DI
00880304225558
Brand
MAX-TI
Company
Biomet Orthopedics, LLC
Model
124096
Catalog number
124096
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTCPLIERS, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304225558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304225558008803042255588803042255580880304225558

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB71190TBS BASICSACME ENTERPRISE.HTC2026-05-22
D9281301290SLOTTED SPONGE FORCEPS, 15CMW.H. Holden, Inc.HTC2026-01-05
03662663217651Posterior Cervical Removal InstrumentsHighridge Medical, LLCHTC2025-12-17
00840314270207gSourceGSOURCE LLCHTC2025-11-17
00840314270214gSourceGSOURCE LLCHTC2025-11-17
00885556908860EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911570EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911587EVOSSmith & Nephew, Inc.HTC2025-11-11
00841336106109Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106116Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106123Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106130Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
08033390289061ArTTLIMACORPORATE SPAHTC2025-09-25
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B356KJ522130American MedicalsAmerican MedicalsHTC2025-09-12
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