restor3d Veritas rTSA Instrumentation

GUDID 00840097512617

Reamer - Humeral Metaphysis -Large

Restor3d, Inc.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 00840097512617
• NIH Device Record Key: f8c8cf8b-7b74-41c5-ba2a-0fe2eb64e822
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Veritas rTSA Instrumentation
• Version Model Number: 5500-2803
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• 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: false
• 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	00840097512617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243643

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

[00840097512617]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [restor3d Veritas rTSA Instrumentation]

• 00840097516288: Reamer - Humeral Metaphysis - Medium
• 00840097516080: Glenosphere trial kit - (1) Ø40+0 (1) Ø40+4
• 00840097516073: Glenosphere trial kit - (1) Ø36+0 (1) Ø36+4
• 00840097516066: Glenosphere trial kit - (1) Ø32+2 (1) Ø32+4
• 00840097516059: Humeral pin kit - (3) Ø2.0x3 (1) Ø2.8x6
• 00840097516042: Glenoid pin kit - (1) Ø2.0x 7 (1) Ø2.8x 8
• 00840097515755: 7.0 mm Drill Bit
• 00840097515748: Ø 3.8 mm Drill Bit - solid
• 00840097515229: Combination Instrument - Pronged Inserter
• 00840097514772: Humeral Cut Protector - Size L
• 00840097513362: Screw Caddy Lid
• 00840097513355: Screw Caddy Body
• 00840097513348: Screw Caddy Tray Lid
• 00840097513331: Screw Caddy Tray Base
• 00840097513324: Reusable Instrument Main Tray Upper Level
• 00840097513317: Reusable Instrument Main Tray Lid
• 00840097513300: Reusable Instrument Main Tray Base
• 00840097512860: Trial - Spacer Tray
• 00840097512853: Trial - Humeral Stem - Size 8
• 00840097512846: Trial - Humeral Stem - Size 7
• 00840097512839: Trial - Humeral Stem - Size 6
• 00840097512822: Trial - Humeral Stem - Size 5
• 00840097512815: Trial - Humeral Stem - Size 4
• 00840097512808: Trial - Humeral Stem - Size 3
• 00840097512792: Trial - Humeral Stem - Size 2
• 00840097512785: Trial - Humeral Stem - Size 1
• 00840097512778: Trial - Humeral Poly - Standard, +3 lateralization, 40 mm sphere
• 00840097512761: Trial - Humeral Poly - Standard, +3 lateralization, 36 mm sphere
• 00840097512754: Trial - Humeral Poly - Standard, +3 lateralization, 32 mm sphere
• 00840097512747: Trial - Humeral Poly - Standard, neutral lateralization, 40 mm sphere
• 00840097512730: Trial - Humeral Poly -Standard, neutral lateralization, 36 mm sphere
• 00840097512723: Trial - Humeral Poly - Standard, neutral lateralization, 32 mm sphere
• 00840097512716: Inserter Stand - Glenosphere
• 00840097512709: Version Rod
• 00840097512693: Removal Tool - Humeral Stem & Poly
• 00840097512686: Combination Instrument - Impactor - Humeral Poly
• 00840097512679: Inserter - Humeral Stem Detachable Anvil
• 00840097512662: Combination Instrument - Compactor - Humerus - Size 5
• 00840097512655: Combination Instrument - Compactor - Humerus - Size 4
• 00840097512648: Combination Instrument - Compactor - Humerus - Size 3
• 00840097512631: Combination Instrument - Compactor - Humerus - Size 2
• 00840097512624: Combination Instrument - Compactor - Humerus - Size 1
• 00840097512617: Reamer - Humeral Metaphysis -Large
• 00840097512600: Planer - Humeral Calcar - Large
• 00840097512594: Planer - Humeral Calcar - Small
• 00840097512587: Awl - Humeral Canal
• 00840097512570: Removal Tool - Glenosphere
• 00840097512563: Combination Instrument - Left Handed M3 Threaded Rod
• 00840097512556: Combination Instrument - Glenosphere Attachment
• 00840097512549: Drill Guide - Long