Bioplate®

FDA UDI

Class I (US FDA UDI)

by Bioplate, Inc.

Identity

Trade Name: Bioplate® FDA UDI
Generic Name: Manual orthopaedic bender, reusable FDA UDI
Device Name: Plate Bender- Ø2.0 mm - 3 Prong FDA UDI
Model / Reference: ABP4-30-SALE FDA UDI
Description: Plate Bender- Ø2.0 mm - 3 Prong FDA UDI

Identifiers

Catalog Number: ABP4-30-SALE FDA UDI
Primary DI / UDI-DI: M384ABP430SALE0 FDA UDI
FDA Product Code: HXP FDA UDI
GMDN Term: Manual orthopaedic bender, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 4.65 Inch FDA UDI

Category: Manual orthopaedic bender, reusable

Bioplate® by Bioplate, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual orthopaedic bender, reusable.

MESA Small Stature Spinal System — K2M, INC. · Class I
Invictus — ALPHATEC SPINE, INC. · Class I
Kestrel® — Innovasis, Inc. · Class II
Surgical Instrument — OSTEONIC CO., Ltd. · Class I
Invictus — ALPHATEC SPINE, INC. · Class I
Dark Star Deformity — Republic Spine, LLC · Class II
g Source — GSOURCE, LLC. · Class I
CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bioplate, Inc.

Sources (1)

FDA UDI 3187534f-f67f-4ad4-8b2f-647ae608f184 36 fields · synced May 31, 2026