Orthocord Healix Ti

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: ORTHOCORD HEALIX TI FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: HEALIX Ti Anchor w/ORTHOCORD Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 5.5mm FDA UDI
Model / Reference: 222245 FDA UDI
Description: HEALIX Ti Anchor w/ORTHOCORD Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 5.5mm FDA UDI

Identifiers

Catalog Number: 222245 FDA UDI
Primary DI / UDI-DI: 10886705007912 FDA UDI
510(k) Number: K071481 FDA UDI
K082282 FDA UDI
FDA Product Code: HWC FDA UDI
JDR FDA UDI
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
888.3030 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

MRI Safety

MR Conditional FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Orthocord Healix Ti by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K082282 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: Medos International Sàrl

Sources (1)

FDA UDI ed365e9d-98a7-48b3-8ecc-2e0a14cd4faa 37 fields · synced May 30, 2026