PRECICE

GUDID 00195377108555

PRECICE Ti Screw, 6.0x95mm Headless PT

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Arthrodesis nail, distraction

• Primary Device ID: 00195377108555
• NIH Device Record Key: 9b23ec91-4d52-4970-95a2-76853995cc3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE
• Version Model Number: TPT6-950-B-S
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195377108555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230765

FDA Product Code

• HWC: Screw, fixation, bone

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: 2023-10-12
• Device Publish Date: 2023-10-04

On-Brand Devices [PRECICE]

• 00887517001221: Packaged End Cap 12.5mm, +20mm
• 00887517001214: Packaged End Cap 12.5mm, +15mm
• 00887517001207: Packaged End Cap 12.5mm, +10mm
• 00887517001191: Packaged End Cap 12.5mm, +5mm
• 00887517001177: Packaged End Cap 8.5/10.7mm, +20mm
• 00887517001160: Packaged End Cap 8.5/10.7mm, +15mm
• 00887517001153: Packaged End Cap 8.5/10.7mm, +10mm
• 00887517001146: Packaged End Cap 8.5/10.7mm, +5mm
• 00887517001139: Packaged End Cap 8.5/10.7mm, +0mm
• 00887517028389: 5.0mm x 100mm Screw, Fully Threaded
• 00887517028372: 5.0mm x 105mm Screw, Fully Threaded
• 00887517028365: 5.0mm x 110mm Screw, Fully Threaded
• 00887517028358: 5.0mm x 115mm Screw, Fully Threaded
• 00887517028341: 5.0mm x 120mm Screw, Fully Threaded
• 00887517028334: 5.0mm x 20mm Screw, Fully Threaded
• 00887517028327: 5.0mm x 22.5mm Screw, Fully Threaded
• 00887517028310: 5.0mm x 25mm Screw, Fully Threaded
• 00887517028303: 5.0mm x 27.5mm Screw, Fully Threaded
• 00887517028297: 5.0mm x 30mm Screw, Fully Threaded
• 00887517028280: 5.0mm x 32.5mm Screw, Fully Threaded
• 00887517028273: 5.0mm x 35mm Screw, Fully Threaded
• 00887517028266: 5.0mm x 37.5mm Screw, Fully Threaded
• 00887517028259: 5.0mm x 40mm Screw, Fully Threaded
• 00887517028242: 5.0mm x 42.5mm Screw, Fully Threaded
• 00887517028235: 5.0mm x 45mm Screw, Fully Threaded
• 00887517028228: 5.0mm x 47.5mm Screw, Fully Threaded
• 00887517028211: 5.0mm x 50mm Screw, Fully Threaded
• 00887517028204: 5.0mm x 55mm Screw, Fully Threaded
• 00887517028198: 5.0mm x 60mm Screw, Fully Threaded
• 00887517028181: 5.0mm x 65mm Screw, Fully Threaded
• 00887517028174: 5.0mm x 70mm Screw, Fully Threaded
• 00887517028167: 5.0mm x 75mm Screw, Fully Threaded
• 00887517028150: 5.0mm x 80mm Screw, Fully Threaded
• 00887517028143: 5.0mm x 85mm Screw, Fully Threaded
• 00887517028136: 5.0mm x 90mm Screw, Fully Threaded
• 00887517028129: 5.0mm x 95mm Screw, Fully Threaded
• 00887517027658: 3.5mm x 20mm Screw, Partially Threaded
• 00887517027641: 3.5mm x 22.5mm Screw, Partially Threaded
• 00887517027634: 3.5mm x 25mm Screw, Partially Threaded
• 00887517027627: 3.5mm x 27.5mm Screw, Partially Threaded
• 00887517027610: 3.5mm x 30mm Screw, Partially Threaded
• 00887517027603: 3.5mm x 32.5mm Screw, Partially Threaded
• 00887517027597: 3.5mm x 35mm Screw, Partially Threaded
• 00887517027580: 3.5mm x 37.5mm Screw, Partially Threaded
• 00887517027573: 3.5mm x 40mm Screw, Partially Threaded
• 00887517027566: 3.5mm x 42.5mm Screw, Partially Threaded
• 00887517027559: 3.5mm x 45mm Screw, Partially Threaded
• 00887517027542: 3.5mm x 47.5mm Screw, Partially Threaded
• 00887517029928: 4.5mm x 32mm Screw, Locking, PL
• 00887517029911: 4.5mm x 34mm Screw, Locking, PL