Cap Screw Caddy Kit 55-BK-0302

GUDID 00840019937054

Cap Screw Caddy Kit

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019937054
• NIH Device Record Key: c35ee8fb-e525-4b2e-81a1-0cd3528451ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cap Screw Caddy Kit
• Version Model Number: 55-BK-0302
• Catalog Number: 55-BK-0302
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019937054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162300

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840019937054]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

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• 00840019930987 - Reform POCT System: 2024-04-17 Ø4.0 x 36mm Polyaxial Screw - M/L Bias
• 00840019930994 - Reform POCT System: 2024-04-17 Ø4.0 x 38mm Polyaxial Screw - M/L Bias