FDA.reportPublic FDA data

SANTORINI™ Corpectomy Cage System

Primary DI
10888857527591
Brand
SANTORINI™ Corpectomy Cage System
Company
VB Spine LLC
Model
PRO-1098-08
Catalog number
PRO-1098-08
Device description
Trial Size 12x14x26-27 mm, 7°
Published
2021-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K170055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170055000CAPRI Corpectomy Cage SystemK2m2017-04-13MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857527591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885752759110888857527591

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Device Size Text, specify0
Device Size Text, specify0
Length12Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+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
10888857596740NAPA Access System8030-100228030-100222026-07-31
10888857596757NAPA Access System8030-100238030-100232026-07-31
10888857596764NAPA Access System8030-100248030-100242026-07-31
10888857596771NAPA Access System8030-100258030-100252026-07-31
10888857596788NAPA Access System8030-100268030-100262026-07-31
10888857596795NAPA Access System8030-100278030-100272026-07-31
10888857596801NAPA Access System8030-100288030-100282026-07-31
10888857596818NAPA Access System8030-100298030-100292026-07-31
10888857596825NAPA Access System8030-100308030-100302026-07-31
10888857596832NAPA Access System8030-100318030-100312026-07-31
10888857596849NAPA Access System8030-100328030-100322026-07-31
10888857596856NAPA Access System8030-100338030-100332026-07-31
10888857596863NAPA Access System8030-100348030-100342026-07-31
10888857596870NAPA Access System8030-100358030-100352026-07-31
10888857596887NAPA Access System8030-100368030-100362026-07-31
10888857000018NILE™ Alternative Fixation System5416-F03730-SG5416-F03730-SG2015-09-24
10888857000025NILE™ Alternative Fixation System5416-F04730-SG5416-F04730-SG2015-09-24
10888857018587CAYMAN® Plate System1201-160221201-160222015-09-24
10888857018594CAYMAN® Plate System1201-160241201-160242015-09-24
10888857018600CAYMAN® Plate System1201-160261201-160262015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000858063T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-08-01
00889929072929HONOUR® Spacer SystemNEXXT SPINE, LLCMQP2026-07-29
00889929072936HONOUR® Spacer SystemNEXXT SPINE, LLCMQP2026-07-29
18257200151271CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151288CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151295CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151325CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
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