Inserter Shaft

GUDID M739FPT0102

FuseLOX Lumbar Inserter shaft

CAPTIVA SPINE, INC.

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable
Primary Device IDM739FPT0102
NIH Device Record Key2a332d6f-b6e3-4486-a28a-a44217ce3282
Commercial Distribution StatusIn Commercial Distribution
Brand NameInserter Shaft
Version Model NumberFPT0102
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM739FPT0102 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


[M739FPT0102]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-24
Device Publish Date2023-10-16

Devices Manufactured by CAPTIVA SPINE, INC.

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M739985221229 - TransFasten2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Non-Threaded Trocar
M739985221305 - TransFasten2024-03-19 LD (.125” Wire) Marking Pin, 305mm, Non-Threaded Trocar
M739985222229 - TransFasten2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Conical Blunt
M73910110250 - TransFasten - LSF (Lateral Sacroiliac Fusion System)2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 25mm (L)
M73910110300 - TransFasten - LSF (Lateral Sacroiliac Fusion System)2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 30mm (L)
M73910110350 - TransFasten - LSF (Lateral Sacroiliac Fusion System)2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 35mm (L)
M73910110400 - TransFasten - LSF (Lateral Sacroiliac Fusion System)2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 40mm (L)

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