osteo-WEDGE Opening Wedge Bone Locking System

FDA UDI

Class II (US FDA UDI)

by Gramedica

Identity

Trade Name: osteo-WEDGE Opening Wedge Bone Locking System FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: osteo-WEDGE Opening Wedge Bone Locking System -Kit (containing non-sterile single use implants (2.5mm locking bone screws, 3.0mm locking bone screws and bone plates), non-sterile single use temporary tacks and non-sterile reusable instruments). The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. FDA UDI
Model / Reference: OWCarryingCase-Kit FDA UDI
Description: osteo-WEDGE Opening Wedge Bone Locking System -Kit (containing non-sterile single use implants (2.5mm locking bone screws, 3.0mm locking bone screws and bone plates), non-sterile single use temporary tacks and non-sterile reusable instruments). The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. FDA UDI

Identifiers

Catalog Number: CarryingCase FDA UDI
Primary DI / UDI-DI: M621CARRYINGCASE0 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

osteo-WEDGE Opening Wedge Bone Locking System by Gramedica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Gramedica

Sources (1)

FDA UDI 207edf0a-1001-4198-adc7-375e3990995c 35 fields · synced May 30, 2026