C-VBR STGC-LCS21.5

GUDID 10888857403581

Corpectomy Cage, Lordotic, Size 10x12x21.5 mm

K2M, INC.

Vertebral body prosthesis
Primary Device ID10888857403581
NIH Device Record Key8c7aa00a-4f64-457b-ba43-757a7a117ac5
Commercial Distribution Discontinuation2018-06-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameC-VBR
Version Model NumberLordotic-S-21.5
Catalog NumberSTGC-LCS21.5
Company DUNS146060863
Company NameK2M, 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 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(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com

Device Dimensions

Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter
Length10 Millimeter
Height21.5 Millimeter
Angle11 degree
Width12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857403581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLRSpinal vertebral body replacement device - Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

[10888857403581]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2018-03-26

On-Brand Devices [C-VBR]

10888857403772Corpectomy Cage, Lordotic, Size 12x14x39 mm
10888857403765Corpectomy Cage, Lordotic, Size 12x14x35.5 mm
10888857403758Corpectomy Cage, Lordotic, Size 12x14x32 mm
10888857403741Corpectomy Cage, Lordotic, Size 12x14x30.25 mm
10888857403734Corpectomy Cage, Lordotic, Size 12x14x28.5 mm
10888857403727Corpectomy Cage, Lordotic, Size 12x14x26.75 mm
10888857403710Corpectomy Cage, Lordotic, Size 12x14x25 mm
10888857403697Corpectomy Cage, Lordotic, Size 12x14x21.5 mm
10888857403680Corpectomy Cage, Lordotic, Size 12x14x19.75 mm
10888857403673Corpectomy Cage, Lordotic, Size 12x14x18 mm
10888857403666Corpectomy Cage, Lordotic, Size 10x12x39 mm
10888857403659Corpectomy Cage, Lordotic, Size 10x12x35.5 mm
10888857403642Corpectomy Cage, Lordotic, Size 10x12x32 mm
10888857403635Corpectomy Cage, Lordotic, Size 10x12x30.25 mm
10888857403628Corpectomy Cage, Lordotic, Size 10x12x28.5 mm
10888857403611Corpectomy Cage, Lordotic, Size 10x12x26.75 mm
10888857403604Corpectomy Cage, Lordotic, Size 10x12x25 mm
10888857403598Corpectomy Cage, Lordotic, Size 10x12x23.25 mm
10888857403581Corpectomy Cage, Lordotic, Size 10x12x21.5 mm
10888857403574Corpectomy Cage, Lordotic, Size 10x12x19.75 mm
10888857403567Corpectomy Cage, Lordotic, Size 10x12x18 mm
10888857403550Corpectomy Cage, Parallel, Size 12x14x72 mm
10888857403543Corpectomy Cage, Parallel, Size 12x14x65 mm
10888857403536Corpectomy Cage, Parallel, Size 12x14x58 mm
10888857403529Corpectomy Cage, Parallel, Size 12x14x51 mm
10888857403512Corpectomy Cage, Parallel, Size 12x14x44 mm
10888857403505Corpectomy Cage, Parallel, Size 12x14x37 mm
10888857403499Corpectomy Cage, Parallel, Size 12x14x33.5 mm
10888857403482Corpectomy Cage, Parallel, Size 12x14x30 mm
10888857403475Corpectomy Cage, Parallel, Size 12x14x28.25 mm
10888857403468Corpectomy Cage, Parallel, Size 12x14x26.5 mm
10888857403451Corpectomy Cage, Parallel, Size 12x14x24.75 mm
10888857403444Corpectomy Cage, Parallel, Size 12x14x23 mm
10888857403437Corpectomy Cage, Parallel, Size 12x14x21.25 mm
10888857403420Corpectomy Cage, Parallel, Size 12x14x19.5 mm
10888857403413Corpectomy Cage, Parallel, Size 12x14x17.75 mm
10888857403406Corpectomy Cage, Parallel, Size 12x14x16 mm
10888857403390Corpectomy Cage, Parallel, Size 10x12x72 mm
10888857403383Corpectomy Cage, Parallel, Size 10x12x65 mm
10888857403376Corpectomy Cage, Parallel, Size 10x12x58 mm
10888857403369Corpectomy Cage, Parallel, Size 10x12x51 mm
10888857403352Corpectomy Cage, Parallel, Size 10x12x44 mm
10888857403345Corpectomy Cage, Parallel, Size 10x12x37 mm
10888857403338Corpectomy Cage, Parallel, Size 10x12x33.5 mm
10888857403321Corpectomy Cage, Parallel, Size 10x12x30 mm
10888857403314Corpectomy Cage, Parallel, Size 10x12x28.25 mm
10888857403307Corpectomy Cage, Parallel, Size 10x12x26.5 mm
10888857403291Corpectomy Cage, Parallel, Size 10x12x24.75 mm
10888857403284Corpectomy Cage, Parallel, Size 10x12x23 mm
10888857403277Corpectomy Cage, Parallel, Size 10x12x21.25 mm
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