Slimplicity Plus 66-SF-4512-B

GUDID 00840019915717

Fixed Blunt Screws 4.5mm x 12mm

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable

Primary Device ID	00840019915717
NIH Device Record Key	9c195c4c-052c-4da9-aa91-b9798ba024e3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Slimplicity Plus
Version Model Number	66-SF-4512-B
Catalog Number	66-SF-4512-B
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	00840019915717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K060025

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-04-09
Device Publish Date	2019-03-27

Devices Manufactured by PRECISION SPINE, INC.

00840019972475 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 7.5 X 40mm Reform Ti MIS Screw Assembly, Cannulated
00840019972482 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 7.5 X 45mm Reform Ti MIS Screw Assembly, Cannulated
00840019972499 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 7.5 X 50mm Reform Ti MIS Screw Assembly, Cannulated
00840019972505 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 7.5 X 55mm Reform Ti MIS Screw Assembly, Cannulated
00840019972512 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 7.5 X 60mm Reform Ti MIS Screw Assembly, Cannulated
00840019972529 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 7.5 X 70mm Reform Ti MIS Screw Assembly, Cannulated
00840019972536 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 7.5 X 80mm Reform Ti MIS Screw Assembly, Cannulated
00840019972543 - Reform Ti CT Modular MIS Pedicle Screw System	2025-01-30 8.5 X 35mm Reform Ti MIS Screw Assembly, Cannulated

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.