FDA.report

Single-use OsteoSinter® COTTON instrument kit

Primary DI
08437019951450
Brand
Single-use OsteoSinter® COTTON instrument kit
Company
AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
Model
P00413B1
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
08437019951450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08437019951450084370199514508437019951450

GMDN Terms

TermDefinition
Surgical implant/trial-implant/sizer holder, single-useA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.

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
08437019951429OsteoSinter® EVANS wedge 20Wx20Lx6HP00210A12025-03-14
08437019951436OsteoSinter® EVANS wedge 22W x 22L x 6HP00211A12025-03-14
08437019951443Single-use OsteoSinter® EVANS instrument kitP00401B12025-03-14
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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