Indy Standalone

GUDID 00843210159720

PEEK/Titanium Interbody, 20 °, 32mm x 24mm

Altus Spine, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 00843210159720
• NIH Device Record Key: 074a520d-3186-46e3-b9c6-204870d84e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indy Standalone
• Version Model Number: SL32242018
• Company DUNS: 078331322
• Company Name: Altus 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210159720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211837

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

[00843210159720]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-23

On-Brand Devices [Indy Standalone]

• 00843210160030: PEEK/Titanium Interbody, 25 °, 32mm x 24mm
• 00843210160023: PEEK/Titanium Interbody, 25 °, 32mm x 24mm
• 00843210160016: PEEK/Titanium Interbody, 25 °, 32mm x 24mm
• 00843210160009: PEEK/Titanium Interbody, 25 °, 32mm x 24mm
• 00843210159997: PEEK/Titanium Interbody, 25 °, 32mm x 24mm
• 00843210159980: PEEK/Titanium Interbody, 25 °, 32mm x 24mm
• 00843210159973: PEEK/Titanium Interbody, 25 °, 32mm x 24mm
• 00843210159744: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159737: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159720: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159713: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159706: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159690: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159683: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159676: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159669: PEEK/Titanium Interbody, 20 °, 32mm x 24mm
• 00843210159386: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159379: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159362: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159355: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159348: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159331: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159324: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159317: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159300: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210159294: PEEK/Titanium Interbody, 16 °, 32mm x 24mm
• 00843210158969: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158952: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158945: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158938: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158921: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158914: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158907: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158891: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158884: PEEK/Titanium Interbody, 12 °, 32mm x 24mm
• 00843210158877: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158655: PEEK/Titanium Interbody, 8 °, 38mm x 27mm
• 00843210158648: PEEK/Titanium Interbody, 8 °, 38mm x 27mm
• 00843210158471: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158464: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158457: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158440: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158433: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158426: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158419: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158402: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210158396: PEEK/Titanium Interbody, 8 °, 32mm x 24mm
• 00843210160177: PEEK/Titanium Interbody, 25 °, 38mm x 27mm
• 00843210160160: PEEK/Titanium Interbody, 25 °, 38mm x 27mm
• 00843210160153: PEEK/Titanium Interbody, 25 °, 38mm x 27mm