FDA.report

Curiteva Navigation System

Primary DI
B648C5951100
Brand
Curiteva Navigation System
Company
CURITEVA, INC.
Model
C595-110
Device description
Cannulated Bone Awl, Navigation, Prodigy
Published
2023-09-19
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

Contact Domains

Product Codes

CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K223200000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223200000Curiteva Navigation SystemCuriteva, Inc.2023-01-06OLO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B648C5951100PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (877) 928-7483support@curiteva.com

Regulatory Flags

DUNS number
074575332
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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