Implant Kit: Std + Red (Ti) 39-BK-0703

GUDID 00840019937191

Implant Kit: Std + Red (Ti)

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019937191
• NIH Device Record Key: 1af59ca0-73f5-45c0-87ca-b8f655e7adcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant Kit: Std + Red (Ti)
• Version Model Number: 39-BK-0703
• Catalog Number: 39-BK-0703
• 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	00840019937191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121172

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00840019937191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-11
• Device Publish Date: 2019-09-03

Devices Manufactured by PRECISION SPINE, INC.

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• 00840019930949 - Reform POCT System: 2024-04-17 Ø3.5 x 36mm Polyaxial Screw - M/L Bias
• 00840019930956 - Reform POCT System: 2024-04-17 Ø3.5 x 38mm Polyaxial Screw - M/L Bias
• 00840019930963 - Reform POCT System: 2024-04-17 Ø4.0 x 32mm Polyaxial Screw - M/L Bias
• 00840019930970 - Reform POCT System: 2024-04-17 Ø4.0 x 34mm Polyaxial Screw - M/L Bias
• 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