Ultrafix Minimite

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: ULTRAFIX MINIMITE FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: ULTRAFIX MINIMITE STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5 MM) POLYESTER SUTURE, 2.3 MM FDA UDI
Model / Reference: 10211 FDA UDI
Description: ULTRAFIX MINIMITE STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5 MM) POLYESTER SUTURE, 2.3 MM FDA UDI

Identifiers

Catalog Number: 10211 FDA UDI
Primary DI / UDI-DI: 20845854040314 FDA UDI
510(k) Number: K960448 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

Dimensions & Sizes

Size: Outer Diameter — 2.3 Millimeter FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Ultrafix Minimite 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

K960448 also covers:

ULTRAFIX MINIMITE — 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 cfcf1349-0c8b-4399-8bb7-8373eefc0a6c 38 fields · synced Jun 6, 2026