Reliance Posterior Cervical Thoracic System 5-02-020

GUDID 00842566104378

PCT 3.5mm Straight Rod, 20mm

RELIANCE MEDICAL SYSTEMS, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00842566104378
• NIH Device Record Key: 789f6a73-eded-455d-9bd1-b33b7776fc0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reliance Posterior Cervical Thoracic System
• Version Model Number: 5-02-020
• Catalog Number: 5-02-020
• Company DUNS: 064885444
• Company Name: RELIANCE MEDICAL SYSTEMS, LLC
• 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: 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: 801-295-3280
• Email: info@reliance-medical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842566104378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142867

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00842566104378]

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: 2016-12-09

On-Brand Devices [Reliance Posterior Cervical Thoracic System ]

• 00842566104798: 4.0x38mm PCT Screw
• 00842566104781: 4.0x36mm PCT Screw
• 00842566104774: 4.0x34mm PCT Screw
• 00842566104767: 4.0x32mm PCT Screw
• 00842566104750: 4.0x30mm PCT Screw
• 00842566104743: 4.0x28mm PCT Screw
• 00842566104736: 4.0x26mm PCT Screw
• 00842566104729: 4.0x24mm PCT Screw
• 00842566104712: 4.0x22mm PCT Screw
• 00842566104705: 4.0x20 PCT Screw
• 00842566104699: 4.0x18 PCT Screw
• 00842566104682: 4.0x16 PCT Screw
• 00842566104675: 4.0x14 PCT Screw
• 00842566104668: 4.0x12 PCT Screw
• 00842566104651: 4.0x10 PCT Screw
• 00842566104644: 3.5x20 PCT Screw
• 00842566104637: 3.5x18 PCT Screw
• 00842566104620: 3.5x16 PCT Screw
• 00842566104613: 3.5x14 PCT Screw
• 00842566104606: 3.5x12 PCT Screw
• 00842566104590: 3.5x10 PCT Screw
• 00842566104583: 90mm PCT Crosslink II
• 00842566104576: 75mm PCT Crosslink II
• 00842566104569: 50mm PCT Crosslink II
• 00842566104552: 35mm PCT Crosslink II
• 00842566104545: PCT Long Left Hook
• 00842566104538: PCT Long Right Hook
• 00842566104521: PCT Short Left Hook
• 00842566104514: PCT Short Right Hook
• 00842566104507: 90mm PCT Crosslink
• 00842566104491: 75mm PCT Crosslink
• 00842566104484: 50mm PCT Crosslink
• 00842566104477: 35mm PCT Crosslink
• 00842566104460: PCT Ti Rod 3.5/6.0x300
• 00842566104453: Reliance PCT Ti Rod, 3.5/6.0x400
• 00842566104446: PCT 3.5mm Straight Rod, 200mm
• 00842566104439: PCT 3.5mm Straight Rod, 50mm
• 00842566104422: PCT 3.5mm Straight Rod, 45mm
• 00842566104415: PCT 3.5mm Straight Rod, 40mm
• 00842566104408: PCT 3.5mm Straight Rod, 35mm
• 00842566104392: PCT 3.5mm Straight Rod, 30mm
• 00842566104385: PCT 3.5mm Straight Rod, 25mm
• 00842566104378: PCT 3.5mm Straight Rod, 20mm
• 00842566104361: PCT 3.5mm Straight Rod, 15mm
• 00842566104354: 3.5x100mm PCT Curved rod
• 00842566104347: 3.5x95mm PCT Curved Rod
• 00842566104330: 3.5x90mm PCT Curved rod
• 00842566104323: 3.5x85mm PCT Curved Rod
• 00842566104316: 3.5x80mm PCT Curved rod
• 00842566104309: 3.5x75mm PCT Curved rod