FDA.reportPublic FDA data

OsteoSinter® COTTON wedge 15L x 6.5H mm

Primary DI
08437019951573
Brand
OsteoSinter® COTTON wedge 15L x 6.5H mm
Company
AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
Model
P00302B1
Published
2025-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PLFBone Wedge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLFBone WedgeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240461000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437019951573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437019951573084370199515738437019951573

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
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 table
Method

Regulatory Flags#

DUNS number
468566411
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437019951412OsteoSinter® EVANS wedge 18W x 18L x 6HP00209A12025-03-14
08437019951429OsteoSinter® EVANS wedge 20Wx20Lx6HP00210A12025-03-14
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G817103151100SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817103151200SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S101181806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S111121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
00810199190006ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190013ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190020ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24