Palo Alto Corpectomy Cage System 9501-21421L0

GUDID 10888857385993

Corpectomy Cage, Parallel, Size 12x14x21.25 mm

K2M, INC.

Vertebral body prosthesis
Primary Device ID10888857385993
NIH Device Record Keyeb983905-59f0-4fcc-9101-f254ef9895d4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePalo Alto Corpectomy Cage System
Version Model Number9501-21421L0
Catalog Number9501-21421L0
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
Emailsgilbert@k2m.com
Phone+1(703)777-3155
Emailsgilbert@k2m.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com

Device Dimensions

Height21.25 Millimeter
Height21.25 Millimeter
Height21.25 Millimeter
Height21.25 Millimeter
Height21.25 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter
Width14 Millimeter
Length12 Millimeter
Height21.25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857385993 [Primary]
GS110888857403437 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLRSpinal vertebral body replacement device - Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

[10888857385993]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2018-01-15

On-Brand Devices [Palo Alto Corpectomy Cage System]

10888857389090Footprint Trial
10888857389083Footprint Trial
10888857386334Corpectomy Cage, Lordotic, Size 12x14x39 mm, 9°
10888857386327Corpectomy Cage, Lordotic, Size 12x14x35.5 mm, 9°
10888857386310Corpectomy Cage, Lordotic, Size 12x14x32 mm, 9°
10888857386303Corpectomy Cage, Lordotic, Size 12x14x30.25 mm, 9°
10888857386297Corpectomy Cage, Lordotic, Size 12x14x28.5 mm, 9°
10888857386280Corpectomy Cage, Lordotic, Size 12x14x26.75 mm, 9°
10888857386273Corpectomy Cage, Lordotic, Size 12x14x25 mm, 9°
10888857386259Corpectomy Cage, Lordotic, Size 12x14x21.5 mm, 9°
10888857386242Corpectomy Cage, Lordotic, Size 12x14x19.75 mm, 9°
10888857386235Corpectomy Cage, Lordotic, Size 12x14x18 mm, 9°
10888857386228Corpectomy Cage, Lordotic, Size 10x12x39 mm, 11°
10888857386211Corpectomy Cage, Lordotic, Size 10x12x35.5 mm, 11°
10888857386204Corpectomy Cage, Lordotic, Size 10x12x32 mm, 11°
10888857386198Corpectomy Cage, Lordotic, Size 10x12x30.25 mm, 11°
10888857386181Corpectomy Cage, Lordotic, Size 10x12x28.5 mm, 11°
10888857386174Corpectomy Cage, Lordotic, Size 10x12x26.75 mm, 11°
10888857386167Corpectomy Cage, Lordotic, Size 10x12x25 mm, 11°
10888857386150Corpectomy Cage, Lordotic, Size 10x12x23.25 mm, 11°
10888857386143Corpectomy Cage, Lordotic, Size 10x12x21.5 mm, 11°
10888857386136Corpectomy Cage, Lordotic, Size 10x12x19.75 mm, 11°
10888857386129Corpectomy Cage, Lordotic, Size 10x12x18 mm, 11°
10888857386112Corpectomy Cage, Parallel, Size 12x14x72 mm
10888857386105Corpectomy Cage, Parallel, Size 12x14x65 mm
10888857386099Corpectomy Cage, Parallel, Size 12x14x58 mm
10888857386082Corpectomy Cage, Parallel, Size 12x14x51 mm
10888857386075Corpectomy Cage, Parallel, Size 12x14x44 mm
10888857386068Corpectomy Cage, Parallel, Size 12x14x37 mm
10888857386051Corpectomy Cage, Parallel, Size 12x14x33.5 mm
10888857386044Corpectomy Cage, Parallel, Size 12x14x30 mm
10888857386037Corpectomy Cage, Parallel, Size 12x14x28.25 mm
10888857386020Corpectomy Cage, Parallel, Size 12x14x26.5 mm
10888857386013Corpectomy Cage, Parallel, Size 12x14x24.75 mm
10888857386006Corpectomy Cage, Parallel, Size 12x14x23 mm
10888857385993Corpectomy Cage, Parallel, Size 12x14x21.25 mm
10888857385986Corpectomy Cage, Parallel, Size 12x14x19.5 mm
10888857385979Corpectomy Cage, Parallel, Size 12x14x17.75 mm
10888857385962Corpectomy Cage, Parallel, Size 12x14x16 mm
10888857385955Corpectomy Cage, Parallel, Size 10x12x72 mm
10888857385948Corpectomy Cage, Parallel, Size 10x12x65 mm
10888857385931Corpectomy Cage, Parallel, Size 10x12x58 mm
10888857385924Corpectomy Cage, Parallel, Size 10x12x51 mm
10888857385917Corpectomy Cage, Parallel, Size 10x12x44 mm
10888857385900Corpectomy Cage, Parallel, Size 10x12x37 mm
10888857385894Corpectomy Cage, Parallel, Size 10x12x33.5 mm
10888857385887Corpectomy Cage, Parallel, Size 10x12x30 mm
10888857385870Corpectomy Cage, Parallel, Size 10x12x28.25 mm
10888857385863Corpectomy Cage, Parallel, Size 10x12x26.5 mm
10888857385856Corpectomy Cage, Parallel, Size 10x12x24.75 mm
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