Sure-Lok Extended Tab Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Precision Spine, Inc.

Identity

Trade Name: Sure-Lok Extended Tab Pedicle Screw System FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Tray, Instruments and Implants (Complete) FDA UDI
Model / Reference: 48-1100-CA FDA UDI
Description: Tray, Instruments and Implants (Complete) FDA UDI

Identifiers

Catalog Number: 48-1100-CA FDA UDI
Primary DI / UDI-DI: 00840019936804 FDA UDI
510(k) Number: K141397 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system rod Spinal bone set screw

Sure-Lok Extended Tab Pedicle Screw System by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Precision Spine, Inc.

Sources (1)

FDA UDI d6b804b5-8b28-413c-835f-9666d95dc7e6 35 fields · synced Jun 1, 2026