SP-FIX

GUDID 00849044091618

SP-Fix Locking Plate, 35mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00849044091618
• NIH Device Record Key: a1930735-7d90-426b-b25e-c12bb914bb61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP-FIX
• Version Model Number: 188.035
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044091618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102195

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00849044091618]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-07

On-Brand Devices [SP-FIX]

• 00849044092639: Plate Trial, 26mm
• 00849044092622: LP-Ti Barrel Trial, 22mm
• 00849044092547: Trial, 22mm
• 00849044092448: SP-Fix Set Screw Locking Plate, 55mm
• 00849044092431: SP-Fix Set Screw Locking Plate, 50mm
• 00849044092424: SP-Fix Set Screw Locking Plate, 47mm
• 00849044092417: SP-Fix Set Screw Locking Plate, 44mm
• 00849044092400: SP-Fix Set Screw Locking Plate, 41mm
• 00849044092394: SP-Fix Set Screw Locking Plate, 38mm
• 00849044092387: SP-Fix Set Screw Locking Plate, 35mm
• 00849044092370: SP-Fix Set Screw Locking Plate, 32mm
• 00849044092363: SP-Fix Set Screw Locking Plate, 29mm
• 00849044092356: SP-Fix Set Screw Locking Plate, 26mm
• 00849044092349: SP-Fix Double Tab Locking Plate, 55mm
• 00849044092332: SP-Fix Double Tab Locking Plate, 50mm
• 00849044092325: SP-Fix Double Tab Locking Plate, 47mm
• 00849044092318: SP-Fix Double Tab Locking Plate, 44mm
• 00849044092301: SP-Fix Double Tab Locking Plate, 41mm
• 00849044092295: SP-Fix Double Tab Locking Plate, 38mm
• 00849044092288: SP-Fix Double Tab Locking Plate, 35mm
• 00849044092271: SP-Fix Double Tab Locking Plate, 32mm
• 00849044092264: SP-Fix Double Tab Locking Plate, 29mm
• 00849044092257: SP-Fix Double tab Locking Plate, 26mm
• 00849044092240: SP-Fix LP PEEK Barrel Assembly, 22mm
• 00849044092233: SP-Fix LP PEEK Barrel Assembly, 20mm
• 00849044092226: SP-Fix LP PEEK Barrel Assembly, 18mm
• 00849044092219: SP-Fix LP PEEK Barrel Assembly, 16mm
• 00849044092202: SP-Fix LP PEEK Barrel Assembly, 14mm
• 00849044092196: SP-Fix LP PEEK Barrel Assembly, 12mm
• 00849044092189: SP-Fix LP PEEK Barrel Assembly, 10mm
• 00849044092172: Sp-Fix LP PEEK Barrel Assembly, 8mm
• 00849044092165: SP-Fix Standard PEEK Barrel Assembly, 22mm
• 00849044092158: SP-Fix Standard PEEK Barrel Assembly, 20mm
• 00849044092141: SP-Fix Standard PEEK Barrel Assembly, 18mm
• 00849044092134: SP-Fix Standard PEEK Barrel Assembly, 16mm
• 00849044092127: SP-Fix Standard PEEK Barrel Assembly, 14mm
• 00849044092110: SP-Fix Standard PEEK Barrel Assembly, 12mm
• 00849044092103: SP-Fix Standard PEEK Barrel Assembly, 10mm
• 00849044092097: SP-Fix Standard PEEK Barrel Assembly, 8mm
• 00849044092080: SP-Fix Ti Barrel Assembly, 22mm
• 00849044092073: SP-Fix Ti Barrel Assembly, 20mm
• 00849044092066: SP-Fix Ti Barrel Assembly, 18mm
• 00849044092059: SP-Fix Ti Barrel Assembly, 16mm
• 00849044092042: SP-Fix Ti Barrel Assembly, 14mm
• 00849044092035: SP-Fix Ti Barrel Assembly, 12mm
• 00849044092028: SP-Fix Ti Barrel Assembly, 10mm
• 00849044092011: SP-Fix Ti Barrel Assembly, 8mm
• 00849044092004: SP-Fix Ratcheting Rod, 35mm
• 00849044091991: SP-Fix Ratcheting Rod, 30mm
• 00849044091984: SP-Fix Ratcheting Rod, 25mm