ACIS® ProTi 360°™ 108843811

GUDID 00819917020380

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage

Primary Device ID	00819917020380
NIH Device Record Key	d20324b8-e666-4232-8526-b7e2c965e09d
Commercial Distribution Status	In Commercial Distribution
Brand Name	ACIS® ProTi 360°™
Version Model Number	108843811
Catalog Number	108843811
Company DUNS	010968002
Company Name	Tyber Medical LLC
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 Identifiers

Device Issuing Agency	Device ID
GS1	00819917020380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172185

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	2020-02-24
Device Publish Date	2018-04-14

On-Brand Devices [ACIS® ProTi 360°™]

00819917020717	108843612
00819917020700	108843611
00819917020694	108843610
00819917020687	108843609
00819917020670	108843608
00819917020663	108843607
00819917020656	108843606
00819917020649	108843605
00819917020632	108843512
00819917020625	108843511
00819917020618	108843510
00819917020601	108843509
00819917020595	108843508
00819917020588	108843507
00819917020571	108843506
00819917020564	108843505
00819917020557	108843312
00819917020540	108843311
00819917020533	108843310
00819917020526	108843309
00819917020519	108843308
00819917020502	108843307
00819917020496	108843306
00819917020489	108843305
00819917020472	108843012
00819917020465	108843011
00819917020458	108843010
00819917020441	108843009
00819917020434	108843008
00819917020427	108843007
00819917020410	108843006
00819917020403	108843005
00819917020397	108843812
00819917020380	108843811
00819917020373	108843810
00819917020366	108843809
00819917020359	108843808
00819917020342	108843807
00819917020335	108843806
00819917020328	108843805
00819917020311	108843712
00819917020304	108843711
00819917020298	108843710
00819917020281	108843709
00819917020274	108843708
00819917020267	108843707
00819917020250	108843706
00819917020243	108843705
00819917020236	108843412
00819917020229	108843411

Trademark Results [ACIS]

Mark Image Registration \| Serial	Company Trademark Application Date
ACIS 98018300 not registered Live/Pending	ChemValve-Schmid Americas, LLC 2023-05-30
ACIS 88379244 not registered Live/Pending	Sivarts, Inc. 2019-04-10
ACIS 86296121 4691329 Live/Registered	Federal Home Loan Mortgage Corporation 2014-05-30
ACIS 85248128 4242661 Live/Registered	DEPUY SYNTHES, INC. 2011-02-22
ACIS 85040095 not registered Dead/Abandoned	World Energy Systems Incorporated 2010-05-17
ACIS 78061056 2633372 Dead/Cancelled	Coemergence, Inc. 2001-04-30
ACIS 76392450 2677746 Live/Registered	American Council for International Studies, Inc. 2002-04-04
ACIS 76175358 2716264 Dead/Cancelled	CARL ZEISS MICROIMAGING AIS, INC. 2000-11-30
ACIS 75876549 2412450 Live/Registered	American Council for International Studies 1999-12-21
ACIS 75863023 2587168 Dead/Cancelled	GAB Robins North America, Inc. 1999-12-02
ACIS 75532219 not registered Dead/Abandoned	American Council for International Studies 1998-08-06
ACIS 75532119 not registered Dead/Abandoned	American Council for International Studies 1998-08-06