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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
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Implant Tray (Empty) FDA UDI
Model / Reference
48-2000 FDA UDI
Description
Implant Tray (Empty) FDA UDI

Identifiers

Catalog Number
48-2000 FDA UDI
Primary DI / UDI-DI
00840019922692 FDA UDI
510(k) Number
K141397 FDA UDI
FDA Product Code
MNH FDA UDI
MNI FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

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

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Cleared under the same submission

K141397 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Spine, Inc.

Sources (1)

  • FDA UDI e0a706ed-2881-4995-8746-f3c9c43bdbd7 35 fields · synced May 30, 2026