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MetaFix™ PlantarMAX™ Locking Plate

FDA UDI

Class II (US FDA UDI)

by Merete GmbH

Identity

Trade Name
MetaFix™ PlantarMAX™ Locking Plate FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Device Name
TiAl6V4 ELI non-sterile FDA UDI
Model / Reference
left 36 FDA UDI
Description
TiAl6V4 ELI non-sterile FDA UDI

Identifiers

Catalog Number
FH02110 FDA UDI
Primary DI / UDI-DI
04048266131867 FDA UDI
510(k) Number
K120787 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI

Classification

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

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

MetaFix™ PlantarMAX™ Locking Plate by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K120787 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merete GmbH

Sources (1)

  • FDA UDI baf50c98-e7f1-4dfc-809c-1b605e490a79 38 fields · synced Jun 8, 2026