OsteoCentric Headless Compression Screw Fastener Depth Gauge

FDA UDI

Class I (US FDA UDI)

by OsteoCentric Technologies, Inc

Identity

Trade Name: OsteoCentric Headless Compression Screw Fastener Depth Gauge FDA UDI
Generic Name: Surgical depth gauge, reusable FDA UDI
Device Name: OsteoCentric Headless Compression Screw Fastener Depth Gauge Instrument FDA UDI
Model / Reference: EX01-0004 FDA UDI
Description: OsteoCentric Headless Compression Screw Fastener Depth Gauge Instrument FDA UDI

Identifiers

Catalog Number: EX01-0004 FDA UDI
Primary DI / UDI-DI: 00850015496288 FDA UDI
510(k) Number: K200259 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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: Surgical depth gauge, reusable

OsteoCentric Headless Compression Screw Fastener Depth Gauge by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Surgical depth gauge, reusable.

Depth Gauge — I.T.S. GmbH · Class I
FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I

Cleared under the same submission

K200259 also covers:

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 I	Pending data

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Manufacturer

Manufacturer: OsteoCentric Technologies, Inc

Sources (1)

FDA UDI 1e042577-c1ba-43d3-a7ef-19b318816730 36 fields · synced May 30, 2026