Spine Instruments

GUDID 07630971262614

Full Spine Model Scaled 1:2 Medium Full Spine Model Medium

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630971262614
• NIH Device Record Key: 220dbcf6-b608-4425-94eb-36f3c89ebe54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spine Instruments
• Version Model Number: 7.0034
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630971262614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173472

FDA Product Code

• PQC: Pedicle Screw Placement Guide

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

[07630971262614]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-14
• Device Publish Date: 2021-04-06

On-Brand Devices [Spine Instruments]

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