TruShot

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: TruShot FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: TruShot™ FA with Y-Knot® Shallow All-Suture Anchor (1.7 mm) with one #2-0 (3 metric) Hi-Fi® Suture with Needles, for Foot and Ankle FDA UDI
Model / Reference: YSTN20-FA FDA UDI
Description: TruShot™ FA with Y-Knot® Shallow All-Suture Anchor (1.7 mm) with one #2-0 (3 metric) Hi-Fi® Suture with Needles, for Foot and Ankle FDA UDI

Identifiers

Catalog Number: YSTN20-FA FDA UDI
Primary DI / UDI-DI: 20653405988417 FDA UDI
510(k) Number: K182439 FDA UDI
FDA Product Code: MBI 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

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

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

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Cleared under the same submission

K182439 also covers:

TruShot — Conmed Corporation

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 e11f9e96-ca12-4850-ac9d-c7a0b03b9066 37 fields · synced Jun 8, 2026