FDA.reportPublic FDA data

T2 ALPHA

Primary DI
07613327285482
Brand
T2 ALPHA
Company
Stryker Trauma GmbH
Model
2335-1346S
Catalog number
2335-1346S
Device description
Femoral Nail PF, LEFT
Published
2018-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613327285482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613327285482076133272854827613327285482

GMDN Terms

TermDefinition
Femur nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length460Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
330211587
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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07613327376210T2 ALPHA2351-0390S2351-0390S2023-12-13
07613327361797T2 ALPHA2351-3080S2351-3080S2023-05-25
07613327361803T2 ALPHA2351-3100S2351-3100S2023-05-25
07613327406153T2 ALPHA2351-3082S2351-3082S2023-05-25
07613327406184T2 ALPHA2351-3102S2351-3102S2023-05-25
07613327095548T21806-14201806-14202022-04-27
07613153179443T21896-50551896-50552022-01-31
04546540202475T21896-50351896-50352022-01-27
07613153179368T21896-50251896-50252022-01-27
07613153179375T21896-50301896-50302022-01-27
07613153179399T21896-50401896-50402022-01-27
07613153179412T21896-50451896-50452022-01-27
07613153179436T21896-50501896-50502022-01-27
07613153179467T21896-50601896-50602022-01-27
07613153179474T21896-50651896-50652022-01-27
07613153179481T21896-50701896-50702022-01-27
07613153179498T21896-50751896-50752022-01-27
07613153179504T21896-50801896-50802022-01-27
07613153179511T21896-50851896-50852022-01-27
07613153179528T21896-50901896-50902022-01-27

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00887868150340Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150579Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150593Affixus®Zimmer, Inc.HSB2026-03-19
00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
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00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16