TRYPTIK Anterior Intersomatic Cervical cage

GUDID 07640151080990

Cervical Cage / Lordotic

SpineArt SA

Polymeric spinal fusion cage, sterile

Primary Device ID	07640151080990
NIH Device Record Key	1a77644b-0bfe-4ec1-af01-1f17a6c6be22
Commercial Distribution Status	In Commercial Distribution
Brand Name	TRYPTIK Anterior Intersomatic Cervical cage
Version Model Number	TRY-CL 14 10-S
Company DUNS	483016148
Company Name	SpineArt SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter
Width	16 Millimeter
Height	10 Millimeter
Depth	14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640151080990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122366

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-21
Device Publish Date	2015-10-09

On-Brand Devices [TRYPTIK Anterior Intersomatic Cervical cage]

07640151081331	Cervical Cage / Convex
07640151081324	Cervical Cage / Convex
07640151081317	Cervical Cage / Convex
07640151081300	Cervical Cage / Convex
07640151081294	Cervical Cage / Convex
07640151081287	Cervical Cage / Convex
07640151081270	Cervical Cage / Convex
07640151081263	Cervical Cage / Convex
07640151081256	Cervical Cage / Convex
07640151081249	Cervical Cage / Convex
07640151081232	Cervical Cage / Convex
07640151081225	Cervical Cage / Convex
07640151081218	Cervical Cage / Convex
07640151081201	Cervical Cage / Convex
07640151081195	Cervical Cage / Convex
07640151081188	Cervical Cage / Convex
07640151081010	Cervical Cage / Lordotic
07640151081003	Cervical Cage / Lordotic
07640151080990	Cervical Cage / Lordotic
07640151080983	Cervical Cage / Lordotic
07640151080976	Cervical Cage / Lordotic
07640151080969	Cervical Cage / Lordotic
07640151080952	Cervical Cage / Lordotic
07640151080945	Cervical Cage / Lordotic
07640151080938	Cervical Cage / Lordotic
07640151080921	Cervical Cage / Lordotic
07640151080914	Cervical Cage / Lordotic
07640151080907	Cervical Cage / Lordotic
07640151080891	Cervical Cage / Lordotic
07640151080884	Cervical Cage / Lordotic
07640151080877	Cervical Cage / Lordotic
07640151080860	Cervical Cage / Lordotic
07640185342613	Drill Guide 18mm
07640185342606	Drill Guide 16mm
07640185342590	Drill Guide 14mm
07640185342583	Drill Guide 12mm
07640178983168	ZERO-PROFILE IMPLANT HOLDER