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Axi+Line Bunion Correction System

FDA UDI

Class II (US FDA UDI)

by Medartis Inc.

Identity

Trade Name
Axi+Line Bunion Correction System FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
Device Name
3.5mm Cortical Screw - 16mm FDA UDI
Model / Reference
SCR-3516NL FDA UDI
Description
3.5mm Cortical Screw - 16mm FDA UDI

Identifiers

Primary DI / UDI-DI
00817701020622 FDA UDI
510(k) Number
K152548 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile 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

No

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

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Axi+Line Bunion Correction System by Medartis Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.

Cleared under the same submission

K152548 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medartis Inc.

Sources (1)

  • FDA UDI 4eb8e17e-62ae-4ac3-986e-397167346525 34 fields · synced May 31, 2026