TiLock

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name: TiLock FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: 8.5mm Solid Modular Tap FDA UDI
Model / Reference: 1 FDA UDI
Description: 8.5mm Solid Modular Tap FDA UDI

Identifiers

Catalog Number: GM122-S85 FDA UDI
Primary DI / UDI-DI: M719GM122S850 FDA UDI
FDA Product Code: KWQ FDA UDI
KWP FDA UDI
NKB FDA UDI
GMDN Term: Bone tap, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
888.3050 FDA UDI
888.3070 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 8.5 Millimeter FDA UDI

Category: Bone tap, reusable

TiLock by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Mariner MIS — SeaSpine Orthopedics Corporation · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I

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: Genesys Orthopedics Systems LLC

Sources (1)

FDA UDI e514086c-897d-4ccc-871a-0db43f9a52b8 36 fields · synced May 31, 2026