FDA.report

Inspire Porous PEEK Cervical Interbody Fusion System

Primary DI
B648C23510020
Brand
Inspire Porous PEEK Cervical Interbody Fusion System
Company
CURITEVA, INC.
Model
C235-100-2
Device description
Vise Cervical Inserter, 2mm Stop
Published
2023-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions

SubmissionSupplement
K213030000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K213030000Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.2023-02-13ODP

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B648C23510020PrimaryHIBCC0

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes

TypeValueUnit
Depth2Millimeter

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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