TheRay Collared and Collarless Femoral Stem

GUDID 00816127026386

NECK TRIAL, COLLARED STEM, LATERAL, SIZE 1

NEXTSTEP ARTHROPEDIX, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00816127026386
• NIH Device Record Key: e02769bb-2f70-45b3-a557-3ec1555454a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheRay Collared and Collarless Femoral Stem
• Version Model Number: 12-81-0101
• Company DUNS: 060211165
• Company Name: NEXTSTEP ARTHROPEDIX, LLC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816127026386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241875

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

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

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

[00816127026386]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-12
• Device Publish Date: 2024-12-04

On-Brand Devices [TheRay Collared and Collarless Femoral Stem]

• 00816127025303: TheRay Collared Femoral Stem, Size 5, Standard
• 00816127025297: TheRay Collared Femoral Stem, Size 4, Standard
• 00816127025280: TheRay Collared Femoral Stem, Size 3, Standard
• 00816127025273: TheRay Collared Femoral Stem, Size 2, Standard
• 00816127025266: TheRay Collared Femoral Stem, Size 1, Standard
• 00816127025259: TheRay Collared Femoral Stem, Size 0, Standard
• 00816127026997: Box Osteotome, Collared Stem
• 00816127026652: Femoral Prep Tray, Collared Stem
• 00816127026645: Canal Finding Rasp, Collared Stem
• 00816127026638: Starter Broach, Collared Stem
• 00816127026591: Femoral Broach, Collared Stem, Size 9
• 00816127026584: Femoral Broach, Collared Stem, Size 8
• 00816127026577: Femoral Broach, Collared Stem, Size 7
• 00816127026560: Femoral Broach, Collared Stem, Size 6
• 00816127026553: Femoral Broach, Collared Stem, Size 5
• 00816127026546: Femoral Broach, Collared Stem, Size 4
• 00816127026539: Femoral Broach, Collared Stem, Size 3
• 00816127026522: Femoral Broach, Collared Stem, Size 2
• 00816127026515: Femoral Broach, Collared Stem, Size 1
• 00816127026508: Femoral Broach, Collared Stem, Size 0
• 00816127026461: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 9
• 00816127026454: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 8
• 00816127026447: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 7
• 00816127026430: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 6
• 00816127026423: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 5
• 00816127026416: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 4
• 00816127026409: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 3
• 00816127026393: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 2
• 00816127026386: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 1
• 00816127026379: NECK TRIAL, COLLARED STEM, LATERAL, SIZE 0
• 00816127026331: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 9
• 00816127026324: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 8
• 00816127026317: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 7
• 00816127026300: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 6
• 00816127026294: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 5
• 00816127026287: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 4
• 00816127026270: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 3
• 00816127026263: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 2
• 00816127026256: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 1
• 00816127026249: NECK TRIAL, COLLARED STEM, STANDARD, SIZE 0
• 00816127025471: TheRay Collared Femoral Stem, Size 9, Lateralized
• 00816127025464: TheRay Collared Femoral Stem, Size 8, Lateralized
• 00816127025457: TheRay Collared Femoral Stem, Size 7, Lateralized
• 00816127025440: TheRay Collared Femoral Stem, Size 6, Lateralized
• 00816127025433: TheRay Collared Femoral Stem, Size 5, Lateralized
• 00816127025426: TheRay Collared Femoral Stem, Size 4, Lateralized
• 00816127025419: TheRay Collared Femoral Stem, Size 3, Lateralized
• 00816127025402: TheRay Collared Femoral Stem, Size 2, Lateralized
• 00816127025396: TheRay Collared Femoral Stem, Size 1, Lateralized
• 00816127025389: TheRay Collared Femoral Stem, Size 0, Lateralized