TransFasten - LSF, K-wire

GUDID M73910290160

K-wire

CAPTIVA SPINE, INC.

Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use
Primary Device IDM73910290160
NIH Device Record Keyb0f86325-a789-48f2-bb4d-8b9c1162dd94
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransFasten - LSF, K-wire
Version Model Number10-2-9016
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Device Dimensions

Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter
Length457 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM73910290160 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-03
Device Publish Date2024-04-25

Devices Manufactured by CAPTIVA SPINE, INC.

M739102900109 - TransFasten - LSF, General Instrument Tray2024-05-03 Sterilization Case - General Instrument Tray
M73910290020 - TransFasten - LSF, Quick Connect Drill2024-05-03 Quick Connect Drill
M73910290030 - TransFasten-LSF, Tissue Protector2024-05-03 Tissue Protector
M73910290050 - TransFasten-LSF, Implant Driver Shaft2024-05-03 Implant Driver Shaft
M73910290060 - TransFasten-LSF, Offset Guide2024-05-03 Offset Guide
M73910290070 - TransFasten-LSF, Tissue Dilator2024-05-03 Tissue Dilator
M739102901009 - TransFasten-LSF, Plunger Rod2024-05-03 Plunger Rod
M73910290110 - TransFasten - LSF, Implant Filling Tube2024-05-03 Implant Filling Tube
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.