FDA.report

OsteoSinter® EVANS wedge 20Wx20Lx6H

Primary DI
08437019951429
Brand
OsteoSinter® EVANS wedge 20Wx20Lx6H
Company
AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
Model
P00210A1
Published
2025-03-14
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
true

Related Records

Product Codes

CodeName
PLFBone Wedge

Product Code Classifications

CodeDeviceSpecialtyClass
PLFBone WedgeOrthopedic2

Premarket Submissions

SubmissionSupplement
K240461000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240461000OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.2024-12-06PLF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08437019951429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08437019951429084370199514298437019951429

GMDN Terms

TermDefinition
Metallic osteotomy fusion cage, non-customized A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged and consult instructions for use
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Regulatory Flags

DUNS number
468566411
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
08437019951412OsteoSinter® EVANS wedge 18W x 18L x 6HP00209A12025-03-14
08437019951436OsteoSinter® EVANS wedge 22W x 22L x 6HP00211A12025-03-14
08437019951443Single-use OsteoSinter® EVANS instrument kitP00401B12025-03-14
08437019951450Single-use OsteoSinter® COTTON instrument kitP00413B12025-03-14
08437019951467OsteoSinter® EVANS wedge 18W x 18L x 8H mmP00200B12025-03-14
08437019951474OsteoSinter® EVANS wedge 18W x 18L x 10H mmP00201B12025-03-14
08437019951481OsteoSinter® EVANS wedge 18W x 18L x 12H mmP00202B12025-03-14
08437019951498OsteoSinter® EVANS wedge 20W x 20L x 8H mmP00203B12025-03-14
08437019951504OsteoSinter® EVANS wedge 20W x 20L x 10H mmP00204B12025-03-14
08437019951511OsteoSinter® EVANS wedge 20W x 20L x 12H mmP00205B12025-03-14
08437019951528OsteoSinter® EVANS wedge 22W x 22L x 8H mmP00206B12025-03-14
08437019951535OsteoSinter® EVANS wedge 22W x 22L x 10H mmP00207B12025-03-14
08437019951542OsteoSinter® EVANS wedge 22W x 22L x 12H mmP00208B12025-03-14
08437019951559OsteoSinter® COTTON wedge 15L x 4.5H mmP00300B12025-03-14
08437019951566OsteoSinter® COTTON wedge 15L x 5.5H mmP00301B12025-03-14
08437019951573OsteoSinter® COTTON wedge 15L x 6.5H mmP00302B12025-03-14
08437019951580OsteoSinter® COTTON wedge 20L x 4.5H mmP00303B12025-03-14
08437019951597OsteoSinter® COTTON wedge 20L x 5.5H mmP00304B12025-03-14
08437019951603OsteoSinter® COTTON wedge 20L x 6.5H mmP00305B12025-03-14

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