Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®

GUDID B648C725710300

TAP, Ø4.5 X 30mm, UNIVERSAL JOINT (BALL)

CURITEVA, INC.

Cannulated surgical drill bit, reusable

• Primary Device ID: B648C725710300
• NIH Device Record Key: 9a3450f7-ae79-4fed-a587-67859e94ce6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®
• Version Model Number: C725-710-30
• Company DUNS: 074575332
• Company Name: CURITEVA, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com
• Phone: +1 (877) 928-7483
• Email: support@curiteva.com

Device Dimensions

• Length: 30 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C725710300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250845

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B648C725710300]

Moist Heat or Steam Sterilization

[B648C725710300]

Moist Heat or Steam Sterilization

[B648C725710300]

Moist Heat or Steam Sterilization

[B648C725710300]

Moist Heat or Steam Sterilization

[B648C725710300]

Moist Heat or Steam Sterilization

[B648C725710300]

Moist Heat or Steam Sterilization

[B648C725710300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-31
• Device Publish Date: 2025-12-23

On-Brand Devices [Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®]

• B648C7245535VST0: 5.5 x 35mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245535VSD0: 5.5 x 35mm, SELF-DRILLING, VARIABLE LUMBAR SCREW
• B648C7245535FST0: 5.5 x 35mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245535FSD0: 5.5 x 35mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C7245530VST0: 5.5 x 30mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245530VSD0: 5.5 x 30mm, SELF-DRILLING, VARIABLE LUMBAR SCREW
• B648C7245530FST0: 5.5 x 30mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245530FSD0: 5.5 x 30mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C7245525VST0: 5.5 x 25mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245525VSD0: 5.5 x 25mm, SELF-DRILLING, VARIABLE LUMBAR SCREW
• B648C7245525FST0: 5.5 x 25mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245525FSD0: 5.5 x 25mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C7245520VST0: 5.5 x 20mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245520VSD0: 5.5 x 20mm, SELF-DRILLING, VARIABLE LUMBAR SCREW
• B648C7245520FST0: 5.5 x 20mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245520FSD0: 5.5 x 20mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C7245035VST0: 5.0 x 35mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245035VSD0: 5.0 x 35mm, SELF-DRILLING, VARIABLE LUMBAR SCREW
• B648C7245035FST0: 5.0 x 35mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245035FSD0: 5.0 x 35mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C7245030VST0: 5.0 x 30mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245030VSD0: 5.0 x 30mm, SELF-DRILLING, VARIABLE LUMBAR SCREW
• B648C7245030FST0: 5.0 x 30mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245030FSD0: 5.0 x 30mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C7245025VST0: 5.0 x 25mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245025VSD0: 5.0 x 25mm, SELF-DRILLING, VARIABLE LUMBAR SCREW
• B648C7245025FST0: 5.0 x 25mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245025FSD0: 5.0 x 25mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C7245020VST0: 5.0 x 20mm, SELF-TAPPING, VARIABLE LUMBAR SCREW
• B648C7245020FST0: 5.0 x 20mm, SELF-TAPPING, FIXED LUMBAR SCREW
• B648C7245020FSD0: 5.0 x 20mm, SELF-DRILLING, FIXED LUMBAR SCREW
• B648C72440282081: 40 (W) X 28 (D) X 20 (H) X 8° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402820251: 40 (W) X 28 (D) X 20 (H) X 25° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402820201: 40 (W) X 28 (D) X 20 (H) X 20° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402820141: 40 (W) X 28 (D) X 20 (H) X 14° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C72440281881: 40 (W) X 28 (D) X 18 (H) X 8° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402818251: 40 (W) X 28 (D) X 18 (H) X 25° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402818201: 40 (W) X 28 (D) X 18 (H) X 20° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402818141: 40 (W) X 28 (D) X 18 (H) X 14° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C72440281681: 40 (W) X 28 (D) X 16 (H) X 8° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402816251: 40 (W) X 28 (D) X 16 (H) X 25° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402816201: 40 (W) X 28 (D) X 16 (H) X 20° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402816141: 40 (W) X 28 (D) X 16 (H) X 14° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C72440281481: 40 (W) X 28 (D) X 14 (H) X 8° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402814201: 40 (W) X 28 (D) X 14 (H) X 20° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402814141: 40 (W) X 28 (D) X 14 (H) X 14° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C72440281281: 40 (W) X 28 (D) X 12 (H) X 8° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402812141: 40 (W) X 28 (D) X 12 (H) X 14° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C72440281081: 40 (W) X 28 (D) X 10 (H) X 8° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
• B648C724402810141: 40 (W) X 28 (D) X 10 (H) X 14° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK