FDA.report

MATIRA ANTERIOR CERVICAL SYSTEM

Primary DI
B07307K0130100
Brand
MATIRA ANTERIOR CERVICAL SYSTEM
Company
Kalitec Direct LLC
Model
07-K01-3010
Device description
Plate Holder
Published
2018-09-11
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
HTCPliers, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B07307K0130100PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
041956211
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B07315K0120100NIDO Pedicle Screw System15-K01-201015-K01-20102024-05-02
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B07310BRS02300Cosmolock10-BRS-023010-BRS-02302024-01-16
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