SpheRx

GUDID 00887517125071

SpheRx® EXT Rod, 40mm Pre-Bent

Nuvasive, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00887517125071
• NIH Device Record Key: e92741cb-7cfa-4230-a9cd-b591348a2c64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpheRx
• Version Model Number: 7783040
• Company DUNS: 053950783
• Company Name: Nuvasive, 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(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	00887517125071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090981

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[00887517125071]

Moist Heat or Steam Sterilization

[00887517125071]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [SpheRx]

• 00887517524393: SpheRx PPS Open Ins Tray
• 00887517524386: SpheRx PPS Non-Cannulated Screws
• 00887517524379: SpheRx PPS Instrument Tray
• 00887517524362: SpheRx PPS Implant Tray
• 00887517524355: SpheRx PPS Cannulated Screws
• 00887517524324: SpheRx PPS 6.25mm Pre-Assm Screwdriver
• 00887517524317: SpheRx PPS 6.25mm Imp/Ins Set
• 00887517524300: SpheRx PPS 5.5mm Tulip Lock Screws
• 00887517524270: SpheRx PPS Reduction, 5.5mm AUS
• 00887517524263: SpheRx PPS 5.5mm Imp/Ins Set
• 00887517524256: SpheRx 5.5 EXT Ins Set
• 00887517524249: SpheRx 5.5 EXT Imp Set
• 00887517524232: SpheRx II Sphere Rod/Cross Connect Tray
• 00887517524225: SpheRx II Reduction Screw Tray
• 00887517524188: SpheRx II Conventional Rod Tray
• 00887517524171: SpheRx II Anterior Ins Tray 2
• 00887517524164: SpheRx II Anterior Ins Tray 1
• 00887517524157: SpheRx II Anterior Imp Set
• 00887517524140: SpheRx II Hook/Fixed Screw Tray
• 00887517524133: SpheRx II Imp Set
• 00887517524126: SpheRx II Ins Tray 2
• 00887517524102: SpheRx II Ins Tray 1
• 00887517524089: SpheRx 8.5mm Screw Set
• 00887517524065: SpheRx Implant Set
• 00887517524058: SpheRx Instrument Tray 2
• 00887517524041: SpheRx Ins Tray 1
• 00887517524034: SpheRx II MAS Ins Tray
• 00887517524027: SpheRx II Double Lead Screw Tray
• 00887517521712: SpheRx Persuader Set
• 00887517521385: PPS Distractor, Open PLIF TLIF
• 00887517518385: SpheRx DBR Ins Set
• 00887517518378: SpheRx DBR Imp Set
• 00887517518361: SpheRx DBR Demo Kit
• 00887517518354: SpheRx DBR III Rod Only Tray
• 00887517518347: SpheRx DBR III Modular
• 00887517518330: SpheRx DBR III MOD Implants/Instruments
• 00887517518323: SpheRx DBR III Instrument Tray 2
• 00887517518316: SpheRx DBR III Instrument Tray 1
• 00887517518309: SpheRx DBR III Implant Tray
• 00887517518286: SpheRx DBR II Ins Tray 2
• 00887517518279: SpheRx DBR II Ins Tray 1
• 00887517518262: SpheRx DBR II Imp Set
• 00887517514967: Alpha Armada Mini Reduction Towers
• 00887517479419: SpheRx®II DBR®II Screw, 7.5x60mm Poly
• 00887517479402: SpheRx® DBR®II Screw, 7.5x55mm Cann Poly
• 00887517479297: SpheRx® DBR®II Screw, 7.5x50mm Cann Poly
• 00887517479280: SpheRx® DBR®II Screw, 7.5x45mm Cann Poly
• 00887517479273: SpheRx® DBR®II Screw, 7.5x40mm Cann Poly
• 00887517479266: SpheRx® DBR®II Screw, 7.5x35mm Cann Poly
• 00887517479259: SpheRx® DBR®II Screw, 7.5x30mm Cann Poly