FDA.report

N/A

Primary DI
04048266009388
Brand
N/A
Company
Merete GmbH
Model
FH10902
Device description
Bending Instrument 2 (for HV-and BLP-Plates) MetaFix - BLP non-sterile
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications

CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048266009388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048266009388040482660093884048266009388

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(630)869-1092service@merete-medical.com

Regulatory Flags

DUNS number
313267265
Device count
1
DM exempt
false
Premarket exempt
true
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048266076830N/AFH200652024-10-18
04048266054401DuoThread™CB200622024-07-01
04048266076823N/AFH200502024-07-01
04048266077080N/AFH900012024-07-01
04048266078490N/AFP910212024-07-01
04048266167316N/AAI140022024-07-01
04048266183347N/ACH15002D2024-06-28
04048266183354N/ACH15003D2024-06-28
04048266183361N/ACH15004D2024-06-28
04048266183378N/ACH15005D2024-06-28
04048266183385N/ACH15006D2024-06-28
04048266183392N/ACH15009D2024-06-28
04048266183408N/ACH15010D2024-06-28
04048266183415N/ACH15011D2024-06-28
04048266183422N/ACH15012D2024-06-28
04048266183439N/ACH15013D2024-06-28
04048266164346Merete® CS Cortical Screw Fully Threaded3.0 40 T10CR30340T2024-03-19
04048266010322TwistCut™ EndoSorb bioabsorbable Snap-Off Screw 2.5 28FP250282015-10-15
04048266040664OsteoBridge™ Clamping ScrewM3.5GB303122015-10-15
04048266141019MetaFix™ LS Locking Screw3.0 26 T10FH30026S2016-04-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150066919Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2026-03-02
07640187463149Bending Iron SmallBonebridge AGHXP2026-01-16
07640187463156Bending Plier SmallBonebridge AGHXP2026-01-16
07640187463163Cutting PlierBonebridge AGHXP2026-01-16
M711CI1310Opteryx®Innovasis, Inc.HXP2025-06-30
08800071031833SignexOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697369Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697376Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809416068626Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-25
08403207010032Anmuth Medical InternationalAnmuth Medical International, LLCHXP2025-06-09
00763000987336Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-02-28
00841435124707TecometTECOMET INC.HXP2024-12-19
03700569652937Newclip InstrumentsNEWCLIP TECHNICSHXP2024-11-07
00763000837099CD Horizon™ ModuLeX™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HXP2024-10-27
07612334236012NASynthes GmbHHXP2024-10-09
07612334236173NASynthes GmbHHXP2024-10-09
07612334236630NASynthes GmbHHXP2024-10-09
07612334236647NASynthes GmbHHXP2024-10-09
00810112597943MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
00810112597974MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
04719878787055“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXP2024-04-15
0088823306976216mm Locking ScrewBIOMET MICROFIXATION, INCHXP2024-03-25
00888515202146BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXP2024-02-28
00810112592641TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-23
00810112592658TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-23
00810112592481TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-14
00840343719265GEN2SURGIX MEDICAL LLCHXP2024-01-05
00841435122581TecometTECOMET INC.HXP2023-11-30
00841435122598TecometTECOMET INC.HXP2023-11-30
00818069014100TecometTECOMET INC.HXP2023-07-31