FDA.reportPublic FDA data

OsteoBridge™ IDSF Diaphysis Tibial Nail

Primary DI
04048266166661
Brand
OsteoBridge™ IDSF Diaphysis Tibial Nail
Company
Merete GmbH
Model
10 70
Catalog number
GB41007S
Published
2018-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
K181026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181026000OsteoBridge™ IDSF SystemMerete GmbH2018-10-17HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048266166661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048266166661040482661666614048266166661

GMDN Terms#

Term, Definition table
TermDefinition
Diaphysis prosthesisAn artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(630)869-1092service@merete-medical.com

Regulatory Flags#

DUNS number
313267265
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048266076762N/AFH20014FH200142021-11-01
04048266079077OsteoBridge™N/AGA314132021-11-01
04048266079107OsteoBridge™N/AGA316132021-11-01
04048266079114OsteoBridge™N/AGA316152021-11-01
04048266079138OsteoBridge™N/AGA414132021-11-01
04048266079145OsteoBridge™N/AGA414152021-11-01
04048266079152OsteoBridge™N/AGA414202021-11-01
04048266079169OsteoBridge™N/AGA416132021-11-01
04048266079183OsteoBridge™N/AGA416202021-11-01
04048266079190OsteoBridge™N/AGA418132021-11-01
04048266131003OsteoBridge™N/AGA314202021-11-01
04048266138200OsteoBridge™N/AGA414252021-11-01
04048266144294OsteoBridge™N/AGA318152021-11-01
04048266130853OsteoBridge™ IKA Knee Arthrodesis Nailwithout Collar curved 20 300GA220302015-10-15
04048266078780OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 10 130GA110132015-10-15
04048266078797OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 10 150GA110152015-10-15
04048266078827OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 12 150GA112152015-10-15
04048266078841OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 14 130GA114132015-10-15
04048266078858OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 14 150GA114152015-10-15
04048266078872OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 16 130GA116132015-10-15

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
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
07898624869140NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869157NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869164NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869171NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869188NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869195NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869201NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869218NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869225NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869232NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869249NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869256NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06