Ezstart

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: EZSTART FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: EZSTART INTERFERENCE SCREW, 8MM X 15MM, TITANIUM FDA UDI
Model / Reference: EZ0815T FDA UDI
Description: EZSTART INTERFERENCE SCREW, 8MM X 15MM, TITANIUM FDA UDI

Identifiers

Catalog Number: EZ0815T FDA UDI
Primary DI / UDI-DI: 10653405990536 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 15 Millimeter FDA UDI
Width — 8 Millimeter FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Ezstart by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.

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SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
OrthoButton AL — RIVERPOINT MEDICAL LLC · Class II

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: Conmed Corporation

Sources (1)

FDA UDI f6aa4362-ace9-4836-8978-d2467e383c8b 36 fields · synced May 30, 2026