FDA.reportPublic FDA data

Endcap, Standard

Primary DI
09120047303085
Brand
Endcap, Standard
Company
I.T.S. GmbH
Model
118007-10
Catalog number
118007-10
Device description
Endcap, Standard, Cannulated Femur Nail
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132945000CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAILI.T.S. GmbH2014-03-07HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120047303085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120047303085091200473030859120047303085

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303456917
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120116973843Impactor1UI105A1UI105A2024-08-05
09120116973850PF Extension Endcap,+5mm, PPS1F0-15-05A-S1F0-15-05A-S2024-08-05
09120116973874PF Extension Endcap,+10mm, PPS1F0-15-10A-S1F0-15-10A-S2024-08-05
09120116973881PF Extension Endcap,+15mm, PPS1F0-15-15A-S1F0-15-15A-S2024-08-05
09120116973898PF Extension Endcap,+20mm, PPS1F0-15-20A-S1F0-15-20A-S2024-08-05
09120116973867PF Endcap, 0mm PPS1F0-10-30A-S1F0-10-30A-S2024-04-15
09120034300417Bending Iron66252-1466252-142018-11-08
09120034306419Small Plate Bending Iron KM 47-915KM 47-9152018-11-13
09120034306426Small Plate Bending Iron KM 47-916KM 47-9162018-11-13
09120047301883Bending HeaverKJ.206.14KJ.206.142018-11-14
09120047301890Bending HeaverKJ.207.14KJ.207.142018-11-14
09120069815429In-Situ Bending Iron66261662612018-11-08
09120069815436In-Situ Bending Iron66262662622018-11-08
09120069815443In-Situ Bending Iron66263662632018-11-08
09120034302626Fibula Plate PROlock21222-821222-82016-09-08
09120034302633Fibula Plate PROlock21222-621222-62016-09-08
09120034302640Fibula Plate PROlock21222-421222-42016-09-08
09120034302657Fibula Plate PROlock21221-821221-82016-09-08
09120034302664Fibula Plate PROlock21221-621221-62016-09-08
09120034302671Fibula Plate PROlock21221-421221-42016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
10855068008003CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008010CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008027CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008034CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008041CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008058CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008065CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008072CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008089CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008096CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008102CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
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