Veritas rTSA

GUDID 00840097513515

Humeral Liner, 34, Ø36, +0, S

Restor3d, Inc.

Total reverse shoulder prosthesis

• Primary Device ID: 00840097513515
• NIH Device Record Key: 37d85e51-149f-40cb-a95d-c79fb9fb2e89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veritas rTSA
• Version Model Number: 3500-336U1
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097513515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243643

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-02
• Device Publish Date: 2025-08-25

On-Brand Devices [Veritas rTSA]

• 00840097534343: Monoblock Central Post Baseplate, 45 mm
• 00840097534336: Monoblock Central Post Baseplate, 30 mm
• 00840097534329: Monoblock Central Post Baseplate, 15 mm
• 00840097515991: 4.75 mm Locking Screw, 58 mm
• 00840097515984: 4.75 mm Locking Screw, 54 mm
• 00840097515977: 4.75 mm Locking Screw, 50 mm
• 00840097515960: 4.75 mm Locking Screw, 46 mm
• 00840097515953: 4.75 mm Locking Screw, 42 mm
• 00840097515946: 4.75 mm Locking Screw, 38 mm
• 00840097515939: 4.75 mm Locking Screw, 34 mm
• 00840097515922: 00840097515922
• 00840097515915: 4.75 mm Locking Screw, 26 mm
• 00840097515908: 4.75 mm Locking Screw, 22 mm
• 00840097515892: 00840097515892
• 00840097515885: 4.75 mm Locking Screw, 14 mm
• 00840097515878: 4.75 mm Compression Screw, 58 mm
• 00840097515861: 4.75 mm Compression Screw, 54 mm
• 00840097515854: 4.75 mm Compression Screw, 50 mm
• 00840097515847: 4.75 mm Compression Screw, 46 mm
• 00840097515830: 4.75 mm Compression Screw, 42 mm
• 00840097515823: 4.75 mm Compression Screw, 38 mm
• 00840097515816: 4.75 mm Compression Screw, 34 mm
• 00840097515809: 4.75 mm Compression Screw, 30 mm
• 00840097515793: 4.75 mm Compression Screw, 26 mm
• 00840097515786: 4.75 mm Compression Screw, 22 mm
• 00840097515779: 4.75 mm Compression Screw, 18 mm
• 00840097515762: 4.75 mm Compression Screw, 14 mm
• 00840097515649: CoCr Glenosphere w/ Ti Security Screw, 40mm, +8mm
• 00840097515632: CoCr Glenosphere w/ Ti Security Screw, 40mm, +4mm
• 00840097515625: CoCr Glenosphere w/ Ti Security Screw, 40mm, +0mm
• 00840097515618: CoCr Glenosphere w/ Ti Security Screw, 36mm, +8mm
• 00840097515601: CoCr Glenosphere w/ Ti Security Screw, 36mm, +4mm
• 00840097515595: CoCr Glenosphere w/ Ti Security Screw, 36mm, +0mm
• 00840097515588: CoCr Glenosphere w/ Ti Security Screw, 32mm, +8mm
• 00840097515571: CoCr Glenosphere w/ Ti Security Screw, 32mm, +4mm
• 00840097515564: CoCr Glenosphere w/ Ti Security Screw, 32mm, +2mm
• 00840097515557: Humeral Standard Stem, Size 8
• 00840097515540: Humeral Standard Stem, Size 7
• 00840097515533: Humeral Standard Stem, Size 6
• 00840097515526: Humeral Standard Stem, Size 5
• 00840097515519: Humeral Standard Stem, Size 4
• 00840097515502: Humeral Standard Stem, Size 3
• 00840097515496: Humeral Standard Stem, Size 2
• 00840097515489: Humeral Standard Stem, Size 1
• 00840097515472: Humeral Spacer Tray, Size 5+
• 00840097515465: Humeral Spacer Tray, Size 3-5
• 00840097515458: Humeral Spacer Tray, Size 1-2
• 00840097513584: Humeral Liner, 34, Ø40, +3, S
• 00840097513546: Humeral Liner, 34, Ø36, +0, C
• 00840097513539: Humeral Liner, 34, Ø32, +0, C