InSpan®

GUDID 00190361000976

ISP Plate, Assy, 16x37mm

SPINEFRONTIER, INC.

Interspinous spinal fixation implant
Primary Device ID00190361000976
NIH Device Record Key1d605706-302b-450b-9a6d-36fc439cbf8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInSpan®
Version Model NumberIM61002-25
Company DUNS002003243
Company NameSPINEFRONTIER, 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(866)914-7717
Emailcustomerservice@spinefrontier.com

Device Dimensions

Width16 Millimeter
Width16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190361000976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190361000976]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-04-15

On-Brand Devices [InSpan®]

0019036103957016mm InSpan Sizing Trial
0019036103956314mm InSpan Sizing Trial
0019036103955612mm InSpan Sizing Trial
0019036103954910mm InSpan Sizing Trial
001903610395328mm InSpan Sizing Trial
00190361000976ISP Plate, Assy, 16x37mm
00190361000969ISP Plate, Assy, 14x37mm
00190361000952ISP Plate, Assy, 12x37mm
00190361000945ISP Plate, Assy, 10x37mm
00190361000938ISP Plate, Assy, 8x37mm
00190361000921ISP Plate, Assy, 16x39mm
00190361000914ISP Plate, Assy, 14x39mm
00190361000907ISP Plate, Assy, 12x39mm
00190361000891ISP Plate, Assy, 10x39mm
00190361000884ISP Plate, Assy, 8x39mm
00190361000877ISP Plate, Assy, 16x41mm
00190361000860ISP Plate, Assy, 14x41mm
00190361000853ISP Plate, Assy, 12x41mm
00190361000846ISP Plate, Assy, 10x41mm
00190361000839ISP Plate, Assy, 8x41mm
00190361000822ISP Plate, Assy, 16x43mm
00190361000815ISP Plate, Assy, 14x43mm
00190361000808ISP Plate, Assy, 12x43mm
00190361000792ISP Plate, Assy, 10x43mm
00190361000785ISP Plate, Assy, 8x43mm
00190361000778ISP Plate, Assy, 16x45mm
00190361000761ISP Plate, Assy, 14x45mm
00190361000754ISP Plate, Assy, 12x45mm
00190361000747ISP Plate, Assy, 10x45mm
00190361000730ISP Plate, Assy, 8x45mm
00190361000723M5 Set Screw, ISP Plate
00190361000716ISP Plate, 16x37mm
00190361000709ISP Plate, 14x37mm
00190361000693ISP Plate, 12x37mm
00190361000686ISP Plate, 10x37mm
00190361000679ISP Plate, 8x37mm
00190361000662ISP Plate, 16x39mm
00190361000655ISP Plate, 14x39mm
00190361000648ISP Plate, 12x39mm
00190361000631ISP Plate, 10x39mm
00190361000624ISP Plate, 8x39mm
00190361000617ISP Plate, 16x41mm
00190361000600ISP Plate, 14x41mm
00190361000594ISP Plate, 12x41mm
00190361000587ISP Plate, 10x41mm
00190361000570ISP Plate, 8x41mm
00190361000563ISP Plate, 16x43mm
00190361000556ISP Plate, 14x43mm
00190361000549ISP Plate, 12x43mm
00190361000532ISP Plate, 10x43mm

Trademark Results [InSpan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSPAN
INSPAN
85168993 4046830 Live/Registered
SpineFrontier, Inc.
2010-11-04
INSPAN
INSPAN
75565332 not registered Dead/Abandoned
ANDREW CORPORATION
1998-10-05
INSPAN
INSPAN
74194281 1799989 Dead/Cancelled
Intergraph Corporation
1991-08-13

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