FDA.reportPublic FDA data

Cannulated Pedicle Marker

Primary DI
M7399830100300
Brand
Cannulated Pedicle Marker
Company
CAPTIVA SPINE, INC.
Model
98301-0030
Device description
A VIRTUAL ASSEMBLY CONSISTING OF A CANNULATED PEDICLE MARKER COMPONENT, P/N 98301-0030, ASSEMBLED TO A CANNULATED PEDICLE MARKER TUBE COMPONENT, P/N 98301-0031.
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KILPositioner, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KILPositioner, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7399830100300PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
561-277-9480info@captivaspine.com

Regulatory Flags#

DUNS number
836975784
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M739193990906Non-Modular Convex Trial19399-09062026-10-28
M739193996906Non-Modular Lordotic Trial Assembly19399-69062026-10-28
M739223000700Nav Instruments General Tray22300-07002026-10-28
M739223000800Nav Instruments Pedicle Screws Tray22300-08002026-10-28
M739243999005SG Implant Driver-S24399-90052026-10-28
M739253001012Discectomy Prep Tray25300-10122026-10-28
M739985202229Marking Pin98520-22292026-10-28
M739985203229Marking Pin98520-32292026-10-28
M739993165000Tab Break-Off Tool99316-50002026-10-28
M739153997700Cross Connector Driver15399-77002026-10-23
M739153998800Cross Connector Counter Torque15399-88002026-10-23
M739243501000Blade Dilator24350-10002026-10-23
M739243502000Parallel Guide24350-20002026-10-23
M739243503000In-Line Handle24350-30002026-10-23
M739243504000Tissue Dilator24350-40002026-10-23
M739243505000Tissue Protector24350-50002026-10-23
M739243506000Adjustable Parallel Guide24350-60002026-10-23
M739243507000Impaction Sleeve24350-70002026-10-23
M739243508000Self-Feeding Drill24350-80002026-10-23
M739243509000Implant Filling Tube24350-90002026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M739985202229Marking PinCAPTIVA SPINE, INC.KIL2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.KIL2026-10-28
M739983711000Pedicle Marker With HeadCAPTIVA SPINE, INC.KIL2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.KIL2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.KIL2026-10-23
00840277133618Innomed, Inc.INNOMED, INC.KIL2026-04-21
08437019739454WasherCap™ Countersink Positioner 11mmABANZA TECNOMED SL.KIL2026-03-30
06974940306727endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
06974940306758endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
00840277133182Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133199Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133205Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133212Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133229Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133236Innomed, Inc.INNOMED, INC.KIL2026-02-06
06974940306680endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
06974940306697endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
00840277133021Innomed, Inc.INNOMED, INC.KIL2025-11-10
00840277132888Innomed, Inc.INNOMED, INC.KIL2025-10-14
00840277132765Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132772Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132789Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132796Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132802Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132833Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132734Innomed, Inc.INNOMED, INC.KIL2025-08-27
00840277132659Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132666Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132628Innomed, Inc.INNOMED, INC.KIL2025-08-04
00840277132611Innomed, Inc.INNOMED, INC.KIL2025-07-09