Spine Instruments

GUDID 07630971288164

Tap sleeve Ø4.2mm_notched Removable locking handle

Medacta International SA

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID07630971288164
NIH Device Record Key4c00d691-c28d-454f-90ce-2999a47e48a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpine Instruments
Version Model Number03.75.10.0178
Company DUNS488227125
Company NameMedacta International SA
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630971288164 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


[07630971288164]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [Spine Instruments]

07630971216785MectaLIF Oblique Trial 15mm 0°
07630971216778MectaLIF Oblique Trial 13mm 0°
07630971216761MectaLIF Oblique Trial 11mm 0°
07630971216754MectaLIF Oblique Trial 9mm 0°
07630971216747MectaLIF Posterior Trial 15mm 10°
07630971216730MectaLIF Posterior Trial 13mm 10°
07630971216723MectaLIF Posterior Trial 11mm 10°
07630971216716MectaLIF Posterior Trial 9mm 10°
07630971216709MectaLIF Posterior Trial 25mmx15mm 0°
07630971216693MectaLIF Posterior Trial 25mmx13mm 0°
07630971216686MectaLIF Posterior Trial 25mmx11mm 0°
07630971216679MectaLIF Posterior Trial 25mmx9mm 0°
07630971216662MectaLIF Posterior Trial 25mmx7mm 0°
07630971216655MectaLIF Implant Tray - 5 Levels
07630971216648MectaLIF Bone Graft Impactor - Flat
07630971216631MectaLIF Bone Graft Impactor - Angled
07630971216624MectaLIF Bone Graft Impactor - Curved
07630971216617MectaLIF Bone Graft Impactor - Straight
07630971216600MectaLIF Oblique Implant Impactor
07630971216594MectaLIF Posterior Implant Impactor
07630971216563MectaLIF Hammer
07630971216556MectaLIF Bone Filler Block
07630971216549MectaLIF Oblique Inserter incl. Inner Rod
07630971216532MectaLIF Posterior Inserter incl. Inner Rod
07630971216525MectaLIF Oblique Trial 15mm 5°
07630971216518MectaLIF Oblique Trial 13mm 5°
07630971216501MectaLIF Oblique Trial 11mm 5°
07630971216495MectaLIF Oblique Trial 9mm 5°
07630971216488MectaLIF Oblique Trial 7mm 0°
07630040788861MectaLIF Implant Remover
07630040788854MectaLIF Oblique Trial 15mm 10°
07630040788847MectaLIF Oblique Trial 13mm 10°
07630040785761MectaLIF Posterior Trial 25mmx15mm 5°
07630040785754MectaLIF Posterior Trial 25mmx13mm 5°
07630040785747MectaLIF Posterior Trial 25mmx11mm 5°
07630040785730MectaLIF Posterior Trial 25mmx9mm 5°
07630040785723MectaLIF Posterior Trial 25mmx7mm 5°
07630971200593Shaver 15mm / 210 mm - Left
07630971200586Shaver 13mm / 210 mm - Left
07630971200579Shaver 11mm / 210 mm - Left
07630971200562Shaver 9mm / 210 mm - Left
07630971200555Shaver 8mm / 210 mm - Left
07630971200548Shaver 7mm / 210 mm - Left
07630971200531Shaver 15mm / 210 mm - Right
07630971200524Shaver 13mm / 210 mm - Right
07630971200517Shaver 11mm / 210 mm - Right
07630971200500Shaver 9mm / 210 mm - Right
07630971200494Shaver 8mm / 210 mm - Right
07630971200487Shaver 7mm / 210 mm - Right
07630971200470Rasp Right - 45° Angled - Short

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.