FDA.report

Pediatric Nailing Platform | Tibia

Primary DI
00840194429085
Brand
Pediatric Nailing Platform | Tibia
Company
ORTHOPEDIATRICS CORP.
Model
01-1510-0041
Catalog number
01-1510-0041
Device description
3.2mm x 330mm K-Wire, Threaded, 316L
Published
2023-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications

CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194429085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194429085008401944290858401944290850840194429085

GMDN Terms

TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
796416191
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
true

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