SureLOK MIS 3L 63-CP-5525

GUDID 00840019905398

Pedicle Screw Ø5.5 x 25mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	00840019905398
NIH Device Record Key	bfa429d9-7488-46d2-a194-7998d4d318dd
Commercial Distribution Status	In Commercial Distribution
Brand Name	SureLOK MIS 3L
Version Model Number	63-CP-5525
Catalog Number	63-CP-5525
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	true
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	00840019905398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141397

FDA Product Code

MNI	Orthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-04-16
Device Publish Date	2019-04-08

Devices Manufactured by PRECISION SPINE, INC.

00840019970969 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 4.5 X 25mm Reform MC MIS Screw Assembly, Cannulated
00840019971003 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 K-Wire, NI Beveled
00840019971577 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 4.5 X 25mm Reform MC MIS Screw Assembly, Cannulated
00840019971584 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 4.5 X 30mm Reform MC MIS Screw Assembly, Cannulated
00840019971591 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 4.5 X 35mm Reform MC MIS Screw Assembly, Cannulated
00840019971607 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 4.5 X 40mm Reform MC MIS Screw Assembly, Cannulated
00840019971614 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 4.5 X 45mm Reform MC MIS Screw Assembly, Cannulated
00840019971621 - Reform Ti CT Modular MIS Pedicle Screw System	2024-11-08 5.0 X 25mm Reform MC MIS Screw Assembly, Cannulated

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