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Aptus

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref A-4856.34

by Medartis Inc.

Identity

Trade Name
2.8 TriLock Dist.Hum.Pl Medial, 10H, R EUDAMED
APTUS FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Device Name
Bone plates (sterile, non-sterile) EUDAMED
2.8 TriLock Dist.Hum.Pl Medial, 10H, R FDA UDI
Model / Reference
A-4856.34 EUDAMEDFDA UDI
Description
2.8 TriLock Dist.Hum.Pl Medial, 10H, R FDA UDI

Identifiers

Catalog Number
A-4856.34 FDA UDI
Primary DI / UDI-DI
07630037895596 EUDAMEDFDA UDI
Basic UDI-DI
76300378020P6 EUDAMED
510(k) Number
K112560 FDA UDI
FDA Product Code
HRS FDA UDI
EMDN Code
P09120599 BONE FIXATION PLATES - OTHER EUDAMED
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Aptus by Medartis Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K112560 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medartis Inc.

Sources (2)

  • FDA UDI f3ef8608-6f2b-49b3-89e5-822d44f54821 35 fields · synced Oct 6, 2026
  • EUDAMED 248be3cf-6f9f-4dd8-b373-837022015eda 61 fields · synced Jul 24, 2026