Invictus

GUDID 00190376188751

Cannulated Polyaxial Screw, Ø4.5 X 55mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190376188751
NIH Device Record Key3472adf0-4533-4277-b9c2-d1785c9806e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameInvictus
Version Model Number15005-045-055
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

Device Dimensions

Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter
Length55 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]
GS100190376188751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


[00190376188751]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [Invictus]

00190376240664Pedicle Hook, 12.5mm
00190376240657Pedicle Hook, 11.5mm
00190376234168Open-Closed Revision Connector, 14mm
00190376234151Open-Closed Revision Connector, 13mm
00190376234144Open-Closed Revision Connector, 12mm
00190376234137Open-Closed Revision Connector, 11mm
00190376234120Closed-Side Loading Revision Connector, 18mm
00190376234113Closed-Side Loading Revision Connector, 17mm
00190376234106Closed-Side Loading Revision Connector, 16mm
00190376234090Closed-Side Loading Revision Connector, 15mm
00190376234083Closed-Side Loading Revision Connector, 14mm
00190376234076Closed-Side Loading Revision Connector, 13mm
00190376234069Closed-Side Loading Revision Connector, 12mm
00190376234052Closed-Side Loading Revision Connector, 11mm
00190376234045Open-Closed Revision Connector, 18mm
00190376234038Open-Closed Revision Connector, 17mm
00190376234021Open-Closed Revision Connector, 16mm
00190376234014Open-Closed Revision Connector, 15mm
00190376233598Angled Hook, Left, Long, 12.5mm
00190376233581Angled Hook, Left, Long, 11.5mm
00190376233574Angled Hook, Left, Long, 10.5mm
00190376233567Angled Hook, Left, Long, 9.5mm
00190376233550Angled Hook, Left, Long, 8.5mm
00190376233543Angled Hook, Left, Long, 7.5mm
00190376233536Angled Hook, Left, Long, 6.5mm
00190376233529Angled Hook, Left, Long, 5.5mm
00190376233512Angled Hook, Left, 12.5mm
00190376233505Angled Hook, Left, 11.5mm
00190376233499Angled Hook, Left, 10.5mm
00190376233482Angled Hook, Left, 9.5mm
00190376233475Angled Hook, Left, 8.5mm
00190376233321Offset Hook, Right, 12.5mm
00190376233314Offset Hook, Right, 11.5mm
00190376233307Offset Hook, Right, 10.5mm
00190376233291Offset Hook, Right, 9.5mm
00190376233284Offset Hook, Right, 8.5mm
00190376233277Offset Hook, Right, 7.5mm
00190376233260Offset Hook, Right, 6.5mm
00190376233253Offset Hook, Right, 5.5mm
00190376233246Angled Hook, Left, 7.5mm
00190376233239Angled Hook, Left, 6.5mm
00190376233222Angled Hook, Left, 5.5mm
00190376233055Angled Hook, Right, Long, 12.5mm
00190376233048Angled Hook, Right, Long, 11.5mm
00190376233031Angled Hook, Right, Long, 10.5mm
00190376233024Angled Hook, Right, Long, 9.5mm
00190376233017Angled Hook, Right, Long, 8.5mm
00190376233000Angled Hook, Right, Long, 7.5mm
00190376232997Angled Hook, Right, Long, 6.5mm
00190376232980Angled Hook, Right, Long, 5.5mm

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