FDA.reportPublic FDA data

MetaStep™

Primary DI
04048266165183
Brand
MetaStep™
Company
Merete GmbH
Model
FH14100
Device description
MetaStep Saw Template 24 x 10 x 10.5 non-sterile
Published
2021-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048266165183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048266165183040482661651834048266165183

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
313267265
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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

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Primary DI, Brand, Company table
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00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
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B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
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00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17