FDA.reportPublic FDA data

AUTOBAHN

Primary DI
00193982471439
Brand
AUTOBAHN
Company
GLOBUS MEDICAL, INC.
Model
1257.1034
Catalog number
1257.1034
Device description
AUTOBAHN EVO Antegrade Femoral Nail, 10x340mm, PF, Left, Ti
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HWCScrew, fixation, bone
JDSNAIL, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220659000AUTOBAHN(R) EVO Femoral NailsGlobus Medical, Inc.2022-09-09HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982471439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982471439001939824714391939824714390193982471439

GMDN Terms#

Term, Definition table
TermDefinition
Femur intramedullary nailA rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
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
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
00193982003630N/A6190.00266190.00262026-08-14
00193982016340N/A6178.01676178.01672026-08-14
00193982096274ANTHEM2170.10362170.10362026-08-14
00193982096298ANTHEM2170.10382170.10382026-08-14
00193982096311ANTHEM2170.10402170.10402026-08-14
00193982101909ANTHEM2170.20362170.20362026-08-14
00193982101923ANTHEM2170.20382170.20382026-08-14
00193982101947ANTHEM2170.20402170.20402026-08-14
00193982141097HEDRON1208.0109S1208.0109S2026-08-14
00193982141103HEDRON1208.0111S1208.0111S2026-08-14
00193982141110HEDRON1208.0113S1208.0113S2026-08-14
00193982141127HEDRON1208.0115S1208.0115S2026-08-14
00193982141134HEDRON1208.0117S1208.0117S2026-08-14
00193982141141HEDRON1208.0211S1208.0211S2026-08-14
00193982141158HEDRON1208.0213S1208.0213S2026-08-14
00193982141165HEDRON1208.0215S1208.0215S2026-08-14
00193982141172HEDRON1208.0217S1208.0217S2026-08-14
00193982141189HEDRON1208.0313S1208.0313S2026-08-14
00193982141196HEDRON1208.0315S1208.0315S2026-08-14
00193982141202HEDRON1208.0317S1208.0317S2026-08-14

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Primary DI, Brand, Company table
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07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620919Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
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07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
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07901125620711Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26