FDA.reportPublic FDA data

BIO-MODULAR®

Primary DI
00880304366213
Brand
BIO-MODULAR®
Company
Biomet Orthopedics, LLC
Model
406680
Catalog number
406680
Published
2017-07-28
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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304366213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304366213008803043662138803043662130880304366213

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head prosthesis trial, reusableA copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
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
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
09348215164577Longboard Trial Neck LOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164584Longboard Trial Neck SOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164591Longboard Trial Neck HOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
G791EFTEMPS080WishFIXRed Star Contract Manufacturing Inc.HWT2025-10-06
07613327524536INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524543INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524550INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327548716InstrumentHowmedica Osteonics Corp.HWT2024-02-22
07613327565850INSTRUMENTHowmedica Osteonics Corp.HWT2024-01-08
09348215082017Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082024Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082031Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082048Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082055Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215084998Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085001Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085018Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085025Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085032Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085049Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085056Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085063Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085070Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085087Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085094Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085100Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085117Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20