TrellOss®-A SA

GUDID 00840067208168

ALIF SA Oblique Inserter

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840067208168
• NIH Device Record Key: 4540df0a-bfaf-40ea-9a89-d0f329ad2c78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrellOss®-A SA
• Version Model Number: 431H0003
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, 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

Customer Support Contacts

• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067208168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202230

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

[00840067208168]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

On-Brand Devices [TrellOss®-A SA]

• 00840067206690: TrellOss-A SA, Screws, Implant Case
• 00840067206683: TrellOss-A SA, Hyperlordotic, Implant Case
• 00840067206676: TrellOss-A SA, 30x40, Implant Case
• 00840067206669: TrellOss-A SA, 27x36, Implant Case
• 00840067206652: TrellOss-A SA, 24x32, Implant Case
• 00840067206706: ALIF SA Ratchet T-Handle
• 00840067207383: ALIF SA Trial 30Dx40Wx20H 25°
• 00840067207376: ALIF SA Trial 30Dx40Wx18H 25°
• 00840067207369: ALIF SA Trial 30Dx40Wx16H 25°
• 00840067207352: ALIF SA Trial 30Dx40Wx14H 25°
• 00840067207345: ALIF SA Trial 30Dx40Wx20H 20°
• 00840067207338: ALIF SA Trial 30Dx40Wx18H 20°
• 00840067207321: ALIF SA Trial 30Dx40Wx16H 20°
• 00840067207314: ALIF SA Trial 30Dx40Wx14H 20°
• 00840067207307: ALIF SA Trial 30Dx40Wx20H 14°
• 00840067207291: ALIF SA Trial 30Dx40Wx18H 14°
• 00840067207284: ALIF SA Trial 30Dx40Wx16H 14°
• 00840067207277: ALIF SA Trial 30Dx40Wx14H 14°
• 00840067207260: ALIF SA Trial 30Dx40Wx12H 14°
• 00840067207253: ALIF SA Trial 30Dx40Wx10H 14°
• 00840067207246: ALIF SA Trial 30Dx40Wx08H 14°
• 00840067207239: ALIF SA Trial 30Dx40Wx20H 8°
• 00840067207222: ALIF SA Trial 30Dx40Wx18H 8°
• 00840067207215: ALIF SA Trial 30Dx40Wx16H 8°
• 00840067207208: ALIF SA Trial 30Dx40Wx14H 8°
• 00840067207192: ALIF SA Trial 30Dx40Wx12H 8°
• 00840067207185: ALIF SA Trial 30Dx40Wx10H 8°
• 00840067207178: ALIF SA Trial 30Dx40Wx08H 8°
• 00840067207161: ALIF SA Trial 27Dx36Wx20H 25°
• 00840067207154: ALIF SA Trial 27Dx36Wx18H 25°
• 00840067207147: ALIF SA Trial 27Dx36Wx16H 25°
• 00840067207130: ALIF SA Trial 27Dx36Wx14H 25°
• 00840067207123: ALIF SA Trial 27Dx36Wx20H 20°
• 00840067207116: ALIF SA Trial 27Dx36Wx18H 20°
• 00840067207109: ALIF SA Trial 27Dx36Wx16H 20°
• 00840067207093: ALIF SA Trial 27Dx36Wx14H 20°
• 00840067207086: ALIF SA Trial 27Dx36Wx12H 20°
• 00840067207079: ALIF SA Trial 27Dx36Wx20H 14°
• 00840067207062: ALIF SA Trial 27Dx36Wx18H 14°
• 00840067207055: ALIF SA Trial 27Dx36Wx16H 14°
• 00840067207048: ALIF SA Trial 27Dx36Wx14H 14°
• 00840067207031: ALIF SA Trial 27Dx36Wx12H 14°
• 00840067207024: ALIF SA Trial 27Dx36Wx10H 14°
• 00840067207017: ALIF SA Trial 27Dx36Wx08H 14°
• 00840067207000: ALIF SA Trial 27Dx36Wx20H 8°
• 00840067206997: ALIF SA Trial 27Dx36Wx18H 8°
• 00840067206980: ALIF SA Trial 27Dx36Wx16H 8°
• 00840067206973: ALIF SA Trial 27Dx36Wx14H 8°
• 00840067206966: ALIF SA Trial 27Dx36Wx12H 8°
• 00840067206959: ALIF SA Trial 27Dx36Wx10H 8°