FDA.reportPublic FDA data

TransFasten

Primary DI
M739985222229
Brand
TransFasten
Company
CAPTIVA SPINE, INC.
Model
98522-2229
Device description
LD (.125” Wire) Marking Pin, 229mm, Conical Blunt
Published
2024-03-11
Public version status
New
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
FZXGuide, Surgical, Instrument
KILPositioner, Socket
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
KILPositioner, SocketOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M739985222229PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use 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
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.KIL2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.KIL2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
00810055525164NON NAVIGATED STYLET-OBTURATOR ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525188CANNULATED PROBE IMPACTION CAP ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525195CANNULATED PROBE HANDLE ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525218GRANITE CANNULATED PROBE SHAFTSi-Bone Inc.LXH2026-10-27
00889024702233OsseoFitZimmer, Inc.LXH2026-10-27
00889024702240OsseoFitZimmer, Inc.LXH2026-10-27
00889024702295OsseoFitZimmer, Inc.FZX2026-10-27
00889024702301OsseoFitZimmer, Inc.FZX2026-10-27
00889024702479OsseoFitZimmer, Inc.LXH2026-10-27
04250337119210Counter Pusher, greenJoimax GmbHFZX2026-10-27
04250337119227Counter Pusher, yellowJoimax GmbHFZX2026-10-27
04250337119234Counter Pusher, redJoimax GmbHFZX2026-10-27
M209232940Rose Proximal Cutting GuideBIOPRO, INC.FZX2026-10-27
M20923295Rose Distal Cutting GuideBIOPRO, INC.FZX2026-10-27
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23