BC Reflex Uni Reusable Surgical Instrument Set

FDA UDI

Class II (US FDA UDI)

by Laboratoires Bodycad Inc

Identity

Trade Name: BC Reflex Uni Reusable Surgical Instrument Set FDA UDI
Generic Name: Unicondylar knee prosthesis FDA UDI
Device Name: Reusable Surgical Instrument Set FDA UDI
Model / Reference: 027-003 FDA UDI
Description: Reusable Surgical Instrument Set FDA UDI

Identifiers

Catalog Number: 027-003 FDA UDI
Primary DI / UDI-DI: 00688346002478 FDA UDI
510(k) Number: K211646 FDA UDI
FDA Product Code: HSX FDA UDI
GMDN Term: Unicondylar knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Unicondylar knee prosthesis

BC Reflex Uni Reusable Surgical Instrument Set by Laboratoires Bodycad Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Unicondylar knee prosthesis.

Engage Partial Knee System — Engage Uni, LLC · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Oxford® Partial Knee System — Biomet Orthopedics, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
GENESIS II — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K211646 also covers:

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

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

Manufacturer

Manufacturer: Laboratoires Bodycad Inc

Sources (1)

FDA UDI 2e8cd6c0-d57e-4f71-b391-a614ee7eb771 35 fields · synced May 30, 2026