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Inion Hexalon™ ACL/PCL Screw

FDA UDI

Class II (US FDA UDI)

by Inion , Ltd.

Identity

Trade Name
Inion Hexalon™ ACL/PCL Screw FDA UDI
Generic Name
Bioabsorbable orthopaedic bone screw FDA UDI
Device Name
ACL/PCL screw 7 x 25 mm FDA UDI
Model / Reference
1 FDA UDI
Description
ACL/PCL screw 7 x 25 mm FDA UDI

Identifiers

Catalog Number
ACL-4102 FDA UDI
Primary DI / UDI-DI
M224ACL41029 FDA UDI
510(k) Number
K071464 FDA UDI
FDA Product Code
MAI FDA UDI
HWC FDA UDI
JDR FDA UDI
GMDN Term
Bioabsorbable orthopaedic bone screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Inion Hexalon™ ACL/PCL Screw by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K071464 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inion , Ltd.

Sources (1)

  • FDA UDI 49a9cb3b-321c-4064-878c-6a9823ec1c15 36 fields · synced Jun 1, 2026