FDA.reportPublic FDA data

CAPRI™ Corpectomy Cage System

Primary DI
10888857032200
Brand
CAPRI™ Corpectomy Cage System
Company
VB Spine LLC
Model
2101-23825L5
Catalog number
2101-23825L5
Device description
External Housing, Size 21x25 mm, 30-38 mm, 5 Deg.
Published
2016-12-02
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
10888857032200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885703220010888857032200

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesis, non-sterileA non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Depth21Millimeter
Device Size Text, specify0
Width25Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155mzellers@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
Primary DIBrandModelCatalogPublished
10888857487048EVEREST® Spinal SystemSP-5002SP-50022020-10-13
10888857158313TERRA NOVA® MI Access System1501-900601501-900602021-01-29
10888857596894OZARK Cervical Plate SystemPRO-1427-01PRO-1427-012026-05-28
10888857596719Xia® 3PRO-1432-01PRO-1432-012026-05-12
10888857596726Xia® 3PRO-1432-02PRO-1432-022026-05-12
10888857596733Xia® 3PRO-1432-03PRO-1432-032026-05-12
10888857219656CASCADIA™ Interbody System6101-2224012LL8-G26101-2224012LL8-G22016-12-30
10888857219793CASCADIA™ Interbody System6101-2226014LL8-G26101-2226014LL8-G22015-12-16
10888857220966CASCADIA™ Interbody System6101-2224510LL12-G26101-2224510LL12-G22016-12-30
10888857221093CASCADIA™ Interbody System6101-2226012LL12-G26101-2226012LL12-G22016-12-30
10888857221871CASCADIA™ Interbody System6101-2225014LL15-G26101-2225014LL15-G22016-12-30
10888857221895CASCADIA™ Interbody System6101-2226014LL15-G26101-2226014LL15-G22016-12-30
10888857346420CANYON™ Retractor Systems6401-901076401-901072020-06-18
10888857035553RAVINE® Lateral Access System2701-900722701-900722022-02-14
10888857596900OZARK Cervical Plate SystemPRO-1427-10PRO-1427-102026-05-01
10888857596917OZARK Cervical Plate SystemPRO-1427-12PRO-1427-122026-05-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200151271CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
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18257200151349CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151356CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151363CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151370CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151387CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151394CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151424CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151431CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151448CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151455CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151462CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151479CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151493CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151509CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151523CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151530CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151547CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151561CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151578CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151585CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151592CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151608CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151615CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151622CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151639CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151646CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17