SKYHAWK

GUDID 18257200089543

22W X 50L X 0 DEG X 10H IMPLANT

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200089543
NIH Device Record Key03c964e0-52d2-487a-87c5-54065ba5bd1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKYHAWK
Version Model Number27-3410
Company DUNS927083808
Company NameORTHOFIX INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200089543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


[18257200089543]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-03-12

On-Brand Devices [SKYHAWK]

18257200126088SKYHAWK - BOTTOM LEVEL TRAY, INTERBODY INSTRUMENT CASE
18257200126071SKYHAWK - TOP LEVEL TRAY, INTERBODY INSTRUMENT CASE
18257200126064SKYHAWK - BASE, INTERBODY 22W IMPLANT CASE
18257200126057SKYHAWK - INTERBODY 22W IMPLANT CASE
18257200126040SKYHAWK - BASE, INTERBODY 18W IMPLANT CASE
18257200126033SKYHAWK - INTERBODY 18W IMPLANT CASE
18257200126026SKYHAWK - BASE, INTERBODY INSTRUMENT CASE
18257200126019SKYHAWK - INTERBODY INSTRUMENT CASE
18257200126002BOTTOM TRAY, GENERAL DISCECTOMY CASE #2
18257200125999TOP TRAY, GENERAL DISCECTOMY CASE #2
18257200125982BOTTOM TRAY, GENERAL DISCECTOMY CASE #1
18257200125975TOP TRAY, GENERAL DISCECTOMY CASE #1
18257200125937GENERAL DISCECTOMY CASE #1
18257200125906SKYHAWK - LATERAL PLATE CADDY, LATERAL PLATE CASE
18257200125890SKYHAWK - BONE SCREW CADDY, LATERAL PLATE CASE
18257200125883SKYHAWK - SET SCREW CADDY, LATERAL PLATE CASE
18257200125876SKYHAWK - BASE, LATERAL PLATE CASE
18257200125869SKYHAWK - LATERAL PLATE CASE
18257200110629SKYHAWK - INTERBODY INSTRUMENT TRAY KIT
18257200108916DRIVER
18257200108909FINAL TIGHTENING DRIVER
182572001088935.5MM DRILL
18257200108886AWL
18257200108879AWL SLEEVE
18257200108862RONGEUR, BONE BITING
18257200108855MODULAR IN-LINE HANDLE
18257200105564K-WIRE
1825720010308922W X 60L X 8 DEGREE X 20H TRIAL
1825720010307222W X 60L X 8 DEGREE X 19H TRIAL
1825720010306522W X 60L X 8 DEGREE X 18H TRIAL
1825720010305822W X 60L X 8 DEGREE X 17H TRIAL
1825720010304122W X 60L X 8 DEGREE X 16H TRIAL
1825720010303422W X 60L X 8 DEGREE X 15H TRIAL
1825720010302722W X 60L X 8 DEGREE X 14H TRIAL
1825720010301022W X 60L X 8 DEGREE X 13H TRIAL
1825720010300322W X 60L X 8 DEGREE X 12H TRIAL
1825720010299022W X 60L X 8 DEGREE X 11H TRIAL
1825720010298322W X 60L X 8 DEGREE X 10H TRIAL
1825720010297622W X 60L X 8 DEGREE X 9H TRIAL
1825720010296922W X 60L X 8 DEGREE X 8H TRIAL
1825720010295218W X 60L X 8 DEGREE X 20H TRIAL
1825720010294518W X 60L X 8 DEGREE X 19H TRIAL
1825720010293818W X 60L X 8 DEGREE X 18H TRIAL
1825720010292118W X 60L X 8 DEGREE X 17H TRIAL
1825720010291418W X 60L X 8 DEGREE X 16H TRIAL
1825720010290718W X 60L X 8 DEGREE X 15H TRIAL
1825720010289118W X 60L X 8 DEGREE X 14H TRIAL
1825720010288418W X 60L X 8 DEGREE X 13H TRIAL
1825720010287718W X 60L X 8 DEGREE X 12H TRIAL
1825720010286018W X 60L X 8 DEGREE X 11H TRIAL

Trademark Results [SKYHAWK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SKYHAWK
SKYHAWK
98352937 not registered Live/Pending
Skyhawk Therapeutics, Inc.
2024-01-11
SKYHAWK
SKYHAWK
90468124 not registered Live/Pending
Oro Agri Inc.
2021-01-15
SKYHAWK
SKYHAWK
90132906 not registered Live/Pending
Skyhawk Therapeutics, Inc.
2020-08-24
SKYHAWK
SKYHAWK
90132887 not registered Live/Pending
Skyhawk Therapeutics, Inc.
2020-08-24
SKYHAWK
SKYHAWK
88268046 not registered Live/Pending
Nick Sciabica & Sons, A Corporation
2019-01-18
SKYHAWK
SKYHAWK
88150038 5939502 Live/Registered
Pica Product Development, LLC
2018-10-10
SKYHAWK
SKYHAWK
87979931 5711666 Live/Registered
SKYHAWK THERAPEUTICS, INC.
2018-01-09
SKYHAWK
SKYHAWK
87748443 not registered Live/Pending
SKYHAWK THERAPEUTICS, INC.
2018-01-09
SKYHAWK
SKYHAWK
87734174 not registered Live/Pending
PICA Product Development
2017-12-26
SKYHAWK
SKYHAWK
87250790 5236315 Live/Registered
Peter Fang
2016-11-29
SKYHAWK
SKYHAWK
87090738 not registered Dead/Abandoned
Seagate Technology LLC
2016-07-01
SKYHAWK
SKYHAWK
86938447 5072379 Live/Registered
Gru-Bee Inc.
2016-03-14

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