FDA.reportPublic FDA data

CASPIAN® Spinal System

Primary DI
10888857157828
Brand
CASPIAN® Spinal System
Company
VB Spine LLC
Model
1101-03520FN
Catalog number
1101-03520FN
Device description
MESA®Mini Long Shank Screw, Modified Size Ø3.5x20
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142558000Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m2014-12-22KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857157828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885715782810888857157828

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Outer Diameter3.5Millimeter

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
Primary DIBrandModelCatalogPublished
10888857578951Q Interbody Instruments8020-900168020-900162026-03-03
10888857579866Q Interbody Instruments8020-900158020-900152026-03-03
10888857579880Q Interbody Instruments8020-900148020-900142026-03-03
10888857599710YUKON OCT Spinal SystemPRO-1435PRO-14352026-08-25
10888857556072CASCADIA Interbody System8030-900328030-900322024-01-04
10888857557260CASCADIA Interbody System8030-900008030-900002024-01-04
10888857557277CASCADIA Interbody System8030-900018030-900012024-01-04
10888857383746CASCADIA™ Interbody System7902-900387902-900382021-01-29
10888857383753CASCADIA™ Interbody System7902-900397902-900392021-01-29
10888857383814CASCADIA™ Interbody System7902-900457902-900452021-01-29
10888857313354VIKOS® Allograft System2504-900592504-900592020-01-08
10888857326408VIKOS® Allograft System2504-900572504-900572020-01-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982239862CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239886CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239909CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239923CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239947CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239961CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240240CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240363CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240622CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450151CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450168CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450175CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450182CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450199CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521134QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521219QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521226QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521233QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521240QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521257QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521264QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521271QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982669638CREOGLOBUS MEDICAL, INC.KWP2026-08-14