FDA.reportPublic FDA data

CAPRI™ Corpectomy Cage System

Primary DI
10888857032675
Brand
CAPRI™ Corpectomy Cage System
Company
VB Spine LLC
Model
2101-24636L20
Catalog number
2101-24636L20
Device description
External Housing, Size 28x36 mm, 38-46 mm, 20°
Published
2018-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142016000CAPRIK2m, Inc.2014-11-06MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857032675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885703267510888857032675

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle20degree
Device Size Text, specify0
Height46Millimeter
Length28Millimeter
Width36Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155sgilbert@k2m.com
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10888857596924OZARK Cervical Plate SystemPRO-1427-14PRO-1427-142026-05-01
10888857596931OZARK Cervical Plate SystemPRO-1427-16PRO-1427-162026-05-01
10888857596948OZARK Cervical Plate SystemPRO-1427-18PRO-1427-182026-05-01
10888857218765CASCADIA™ Interbody System6101-2224508LP-G26101-2224508LP-G22015-12-16
10888857218888CASCADIA™ Interbody System6101-2225510LP-G26101-2225510LP-G22015-12-16
10888857218895CASCADIA™ Interbody System6101-2226010LP-G26101-2226010LP-G22015-12-16

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Primary DI, Brand, Company table
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08033726407701DSCSINTEA PLUSTEK SRLMQP2015-10-09
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08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
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08033726407848DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407855DSCSINTEA PLUSTEK SRLMQP2015-10-09
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