Spira-V Open Matrix Corpectomy Cage

GUDID B030SPV1214535310

7° (3.5°/3.5°),  31H Implant

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal fusion cage, non-sterile
Primary Device IDB030SPV1214535310
NIH Device Record Keyb6934b5e-84a8-494d-9794-2144b103b4b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpira-V Open Matrix Corpectomy Cage
Version Model NumberSPV-12145-3531
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030SPV1214535310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030SPV1214535310]

Moist Heat or Steam Sterilization


[B030SPV1214535310]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-05
Device Publish Date2018-07-27

On-Brand Devices [Spira-V Open Matrix Corpectomy Cage]

B030SPV12145353307° (3.5°/3.5°),  33H Implant
B030SPV12145353107° (3.5°/3.5°),  31H Implant
B030SPV12145352907° (3.5°/3.5°),  29H Implant
B030SPV12145352707° (3.5°/3.5°),  27H Implant
B030SPV12145352507° (3.5°/3.5°),  25H Implant
B030SPV12145352307° (3.5°/3.5°),  23H Implant
B030SPV12145352107° (3.5°/3.5°),  21H Implant
B030SPV12145351907° (3.5°/3.5°),  19H Implant
B030SPV12145351707° (3.5°/3.5°),  17H Implant
B030SPV12145351507° (3.5°/3.5°),  15H Implant
B030SPV12145073307° (7°/0°),  33H Implant
B030SPV12145073107° (7°/0°),  31H Implant
B030SPV12145072907° (7°/0°),  29H Implant
B030SPV12145072707° (7°/0°),  27H Implant
B030SPV12145072507° (7°/0°),  25H Implant
B030SPV12145072307° (7°/0°),  23H Implant
B030SPV12145072107° (7°/0°),  21H Implant
B030SPV12145071907° (7°/0°),  19H Implant
B030SPV12145071707° (7°/0°),  17H Implant
B030SPV12145071507° (7°/0°),  15H Implant

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