EDG® Ortho 65mm

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 21342-65-01-10-LN

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 EUDAMED
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 1mm offset depth gauge. FDA UDI
Model / Reference: 21342-65-01-10-LN EUDAMEDFDA 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 1mm offset depth gauge. FDA UDI

Identifiers

Primary DI / UDI-DI: 00865707000438 EUDAMEDFDA UDI
Basic UDI-DI: 08657070004213429J EUDAMED
B-00865707000438 EUDAMED
510(k) Number: K091992 FDA UDI
FDA Product Code: OOL FDA UDI
EMDN Code: Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
GMDN Term: Surgical depth gauge, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Market of Registration: Greece EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

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 — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical depth gauge, single-use.

Surgical Direct — SURGICAL DIRECT, INC. · Class I
CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
General Instrument — ALPHATEC SPINE, INC. · Class I
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 (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Edge Surgical, Inc.

Sources (3)

FDA UDI 202d1f60-fd3c-439e-aa4b-bd97bb090ef2 37 fields · synced Jul 26, 2026
EUDAMED 509d0244-f439-4b0e-b833-d7da302fa5cd 61 fields · synced Jul 12, 2026
EUDAMED b5105e81-be5c-4c0d-bde2-cc2c5f560800 61 fields · synced Jul 26, 2026