Paradigm ClickLok

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: Paradigm ClickLok FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: Paradigm ClickLok Anchor, Blue #2 Suture FDA UDI
Model / Reference: PASA01 FDA UDI
Description: Paradigm ClickLok Anchor, Blue #2 Suture FDA UDI

Identifiers

Catalog Number: PASA01 FDA UDI
Primary DI / UDI-DI: 20653405986765 FDA UDI
510(k) Number: K131035 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

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

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JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
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Cleared under the same submission

K131035 also covers:

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 434c7606-27c7-4347-911d-508e0e5c599a 37 fields · synced May 30, 2026