Ascend

GUDID 00190376477367

12 mm EXPANDABLE CORE, 25-35 mm

ALPHATEC SPINE, INC.

Vertebral body prosthesis
Primary Device ID00190376477367
NIH Device Record Keye227d3fb-7c62-4911-8c2f-6e1c3b7e54ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameAscend
Version Model Number155-0-12-25
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Dimensions

Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter
Height35 Millimeter
Height25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376477367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLRSpinal vertebral body replacement device - Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


[00190376477367]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-05
Device Publish Date2024-10-28

On-Brand Devices [Ascend]

00190376544892Ascend TL VBR Instruments A
00190376544885Ascend TL VBR Instruments B
00190376523576TL VBR DISTRACTOR HANDLE
0019037652331616 mm STATIC CORE, 26 mm
0019037652330916 mm STATIC CORE, 22 mm
0019037652329316 mm STATIC CORE, 18 mm
00190376522012TL VBR 16 mm CORE REMOVAL TOOL
0019037652157216 mm CORE ENDPLATE, BAN 18 x 50 mm 10°
0019037652156516 mm CORE ENDPLATE, BAN 18 x 50 mm 5°
0019037652155816 mm CORE ENDPLATE, BAN 18 x 50 mm 0°
0019037652154116 mm CORE ENDPLATE, BAN 18 x 45 mm 10°
0019037652153416 mm CORE ENDPLATE, BAN 18 x 45 mm 5°
0019037652152716 mm CORE ENDPLATE, BAN 18 x 45 mm 0°
0019037652147316 mm CORE ENDPLATE, BAN 18 x 40 mm 10°
0019037652146616 mm CORE ENDPLATE, BAN 18 x 40 mm 5°
0019037652145916 mm CORE ENDPLATE, BAN 18 x 40 mm 0°
0019037652144216 mm CORE ENDPLATE, BAN 18 x 35 mm 10°
0019037652143516 mm CORE ENDPLATE, BAN 18 x 35 mm 5°
0019037652142816 mm CORE ENDPLATE, BAN 18 x 35 mm 0°
0019037652141116 mm CORE ENDPLATE, BAN 18 x 30 mm 10°
0019037652140416 mm CORE ENDPLATE, BAN 18 x 30 mm 5°
0019037652139816 mm CORE ENDPLATE, BAN 18 x 30 mm 0°
0019037652138116 mm CORE ENDPLATE, BAN 18 x 25 mm 10°
0019037652136716 mm CORE ENDPLATE, BAN 18 x 25 mm 0°
0019037652135016 mm CORE ENDPLATE, BAN 16 x 50 mm 10°
0019037652134316 mm CORE ENDPLATE, BAN 16 x 50 mm 5°
0019037652133616 mm CORE ENDPLATE, BAN 16 x 50 mm 0°
0019037652132916 mm CORE ENDPLATE, BAN 16 x 45 mm 10°
0019037652131216 mm CORE ENDPLATE, BAN 16 x 45 mm 5°
0019037652130516 mm CORE ENDPLATE, BAN 16 x 45 mm 0°
0019037652129916 mm CORE ENDPLATE, BAN 16 x 40 mm 10°
0019037652128216 mm CORE ENDPLATE, BAN 16 x 40 mm 5°
0019037652127516 mm CORE ENDPLATE, BAN 16 x 40 mm 0°
0019037652126816 mm CORE ENDPLATE, BAN 16 x 35 mm 10°
0019037652125116 mm CORE ENDPLATE, BAN 16 x 35 mm 5°
0019037652124416 mm CORE ENDPLATE, BAN 16 x 35 mm 0°
0019037652123716 mm CORE ENDPLATE, BAN 16 x 30 mm 10°
0019037652122016 mm CORE ENDPLATE, BAN 16 x 30 mm 5°
0019037652121316 mm CORE ENDPLATE, BAN 16 x 30 mm 0°
0019037652120616 mm CORE ENDPLATE, BAN 16 x 25 mm 10°
0019037652119016 mm CORE ENDPLATE, BAN 16 x 25 mm 5°
0019037652118316 mm CORE ENDPLATE, BAN 16 x 25 mm 0°
0019037652089616 mm CORE ENDPLATE, LAT 22 x 60 mm 10°
0019037652088916 mm CORE ENDPLATE, LAT 22 x 60 mm 5°
0019037652087216 mm CORE ENDPLATE, LAT 22 x 60 mm 0°
0019037652086516 mm CORE ENDPLATE, LAT 22 x 55 mm 10°
0019037652085816 mm CORE ENDPLATE, LAT 22 x 55 mm 5°
0019037652084116 mm CORE ENDPLATE, LAT 22 x 55 mm 0°
0019037652083416 mm CORE ENDPLATE, LAT 22 x 50 mm 10°
0019037652081016 mm CORE ENDPLATE, LAT 22 x 50 mm 0°

Trademark Results [Ascend]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASCEND
ASCEND
98806799 not registered Live/Pending
Madsen Capital Group, LLC
2024-10-17
ASCEND
ASCEND
98777674 not registered Live/Pending
Bass Pro Intellectual Property, L.L.C.
2024-09-30
ASCEND
ASCEND
98747645 not registered Live/Pending
The Chevy Chase Land Company
2024-09-12
ASCEND
ASCEND
98732659 not registered Live/Pending
ARMSTRONG GLOBAL HOLDINGS, INC.
2024-09-04
ASCEND
ASCEND
98672455 not registered Live/Pending
Ascend Holdco LLC
2024-07-29
ASCEND
ASCEND
98664526 not registered Live/Pending
Coastland Residential, Inc
2024-07-24
ASCEND
ASCEND
98547972 not registered Live/Pending
Ever Accountable LLC
2024-05-13
ASCEND
ASCEND
98544723 not registered Live/Pending
A.R.E. ACCESSORIES, LLC
2024-05-10
ASCEND
ASCEND
98445347 not registered Live/Pending
Temeda, LLC
2024-03-12
ASCEND
ASCEND
98389079 not registered Live/Pending
The Chevy Chase Land Company
2024-02-02
ASCEND
ASCEND
98235297 not registered Live/Pending
GEOSITE Inc.
2023-10-23
ASCEND
ASCEND
98205508 not registered Live/Pending
Ascend Capventures Inc.
2023-10-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.