FDA.report

TRIAL PLATE

Primary DI
08056693028090
Brand
TRIAL PLATE
Company
INTRAUMA SPA
Model
T120.71XX
Catalog number
T120.71XX
Device description
Trial Plate for KITE Malleolus
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K230623000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230623000KITE Distal Fibula KitIntrauma S.P.A2023-09-01HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08056693028090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08056693028090080566930280908056693028090

GMDN Terms

TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
387588051
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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