FDA.reportPublic FDA data

ALPS Proximal Tibia

Primary DI
00887868244308
Brand
ALPS Proximal Tibia
Company
Biomet Orthopedics, LLC
Model
SSI004370
Catalog number
SSI004370
Published
2018-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868244308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868244308008878682443088878682443080887868244308

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width2.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24
00880304434370Vanguard® Knee System1842811842812015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613154605453MATTAStryker GmbHHRS2025-09-16
07613154320288MATTAStryker GmbHHRS2023-10-20
07613154320332MATTAStryker GmbHHRS2023-10-20
07613154320349MATTAStryker GmbHHRS2023-10-20
07613154320356MATTAStryker GmbHHRS2023-10-20
07613154320363MATTAStryker GmbHHRS2023-10-20
07613154320370MATTAStryker GmbHHRS2023-10-20
07613154320387MATTAStryker GmbHHRS2023-10-20
07613154320394MATTAStryker GmbHHRS2023-10-20
07613154320400MATTAStryker GmbHHRS2023-10-20
07613154320417MATTAStryker GmbHHRS2023-10-20
07613154320455MATTAStryker GmbHHRS2023-10-20
07613154320479MATTAStryker GmbHHRS2023-10-20
07613154320516MATTAStryker GmbHHRS2023-10-20
07613154320530MATTAStryker GmbHHRS2023-10-20
07613154320547MATTAStryker GmbHHRS2023-10-20
07613154320608MATTAStryker GmbHHRS2023-10-20
07613154320622MATTAStryker GmbHHRS2023-10-20
07613154320653MATTAStryker GmbHHRS2023-10-20
07613154320677MATTAStryker GmbHHRS2023-10-20
07613154320707MATTAStryker GmbHHRS2023-10-20
07613154320714MATTAStryker GmbHHRS2023-10-20
07613154320721MATTAStryker GmbHHRS2023-10-20
07613154320752MATTAStryker GmbHHRS2023-10-20
07613154320783MATTAStryker GmbHHRS2023-10-20
07613154320790MATTAStryker GmbHHRS2023-10-20
07613154320806MATTAStryker GmbHHRS2023-10-20
07613154320813MATTAStryker GmbHHRS2023-10-20
07613154320882MATTAStryker GmbHHRS2023-10-20
07613154320943MATTAStryker GmbHHRS2023-10-20