FDA.reportPublic FDA data

OsteoBridge™ IDSF Diaphysis Tibial Nail

Primary DI
04048266166678
Brand
OsteoBridge™ IDSF Diaphysis Tibial Nail
Company
Merete GmbH
Model
10 90
Catalog number
GB41009S
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
HBSInstrument, Clip Forming/Cutting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBSInstrument, Clip Forming/CuttingNeurology1

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
04048266166678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048266166678040482661666784048266166678

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
Length90Millimeter
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
00849233010437BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
00849233010444BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
00849233010635Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
30849233010438BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010441BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010632Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
07899893233069NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-31
07899893262038NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-27
08903993392645EXPERT TIBIA NAILAuxein Medical Private LimitedHBS2020-10-21
07540194008572SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008589SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008596SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008602SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008619SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008626SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008633SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008640SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008657SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008664SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008671SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008688SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008695SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008701SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008718SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008725SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008732SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008749SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008756SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008763SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008770SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12