Fms

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name: FMS FDA UDI
Generic Name: Arthroscopic shaver system blade, single-use FDA UDI
Device Name: FMS Mini Round Burr Shaver Blades 2.0mm FDA UDI
Model / Reference: 287735 FDA UDI
Description: FMS Mini Round Burr Shaver Blades 2.0mm FDA UDI

Identifiers

Catalog Number: 287735 FDA UDI
Primary DI / UDI-DI: 10886705000593 FDA UDI
510(k) Number: K954465 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Arthroscopic shaver system blade, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Arthroscopic shaver system blade, single-use

Fms by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic shaver system blade, single-use.

DYONICS / SYNOVATOR — Smith & Nephew, Inc. · Class I
SharkCut — Techcord co., Ltd · Class I
SharkCut — Techcord co., Ltd · Class I
Arthrex® — Arthrex, Inc. · Class I
FMS — Medos International Sàrl · Class II
STERLING — Conmed Corporation · Class I
VOLMED BRASIL — VOLMED BRASIL EQUIPAMENTOS LTDA · Class I
SharkCut — Techcord co., Ltd · Class I

Cleared under the same submission

K954465 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: DePuy Mitek, Inc.

Sources (1)

FDA UDI ab73f460-4a84-4629-a958-692dcd6e15f8 37 fields · synced Jun 1, 2026