EDG® Ortho 65mm

FDA UDI

Class II (US FDA UDI)

by Edge Surgical, Inc.

Identity

Trade Name: EDG® Ortho 65mm FDA UDI
Generic Name: Surgical depth gauge, single-use FDA UDI
Device Name: EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 4mm offset depth gauge FDA UDI
Model / Reference: 21342-65-01-40-LN FDA UDI
Description: EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 4mm offset depth gauge FDA UDI

Identifiers

Primary DI / UDI-DI: 00865707000445 FDA UDI
510(k) Number: K091992 FDA UDI
FDA Product Code: OOL FDA UDI
GMDN Term: Surgical depth gauge, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 65 Millimeter FDA UDI

Category: Surgical depth gauge, single-use

EDG® Ortho 65mm by Edge Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical depth gauge, single-use.

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FuzeFix Large — FUSION ORTHOPEDICS, LLC · Class I
Solanas — ALPHATEC SPINE, INC. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class I

Cleared under the same submission

K091992 also covers:

EDG® Ortho 65mm — EDGE SURGICAL, INC.

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: Edge Surgical, Inc.

Sources (1)

FDA UDI 85421e6d-89eb-4695-9860-a734cb05ae70 37 fields · synced Jun 1, 2026