Identity
- Trade Name
- The Big Easy® FDA UDI
- Generic Name
- Ossicular prosthesis, partial FDA UDI
- Device Name
- PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM FDA UDI
- Model / Reference
- 1156603 FDA UDI
- Description
- PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00721902848216 FDA UDI
- 510(k) Number
- K002897 FDA UDI
- FDA Product Code
- ETB FDA UDIETA FDA UDI
- GMDN Term
- Ossicular prosthesis, partial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3450 FDA UDI874.3495 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 4.5 Millimeter FDA UDI
Category: Ossicular prosthesis, partial
The Big Easy® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ossicular prosthesis, partial.
- Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH · Class II
- PRECISE CENTERED PARTIAL — Grace Medical, Inc. · Class II
- SMART — Gyrus Acmi, Inc. · Class II
- BARTELS BUCKET HANDLE — Grace Medical, Inc. · Class II
- SATALOFF ALTO PARTIAL — Grace Medical, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- MatriX Stapes Prosthesis Titanium — Heinz Kurz · Class II
- TITANIUM PISTON — Grace Medical, Inc. · Class II
Cleared under the same submission
K002897 also covers:
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Big Easy® Piston — MEDTRONIC XOMED, INC.
- Flex H/A® — MEDTRONIC XOMED, INC.
- Flex H/A® — MEDTRONIC XOMED, INC.
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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI a4c9cd82-8131-4b12-a588-59d4000d22ae 36 fields · synced May 30, 2026