← Back to catalogue

Resolve Modular Revision Hip Stem

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1112-2223-RC

by United Orthopedic Corp.

Identity

Trade Name
Resolve Modular Revision Stem EUDAMED
Resolve Modular Revision Hip Stem FDA UDI
Generic Name
Patella prosthesis trial FDA UDI
Device Name
Resolve proximal component trial, Ø23×65mm EUDAMEDFDA UDI
Model / Reference
1112-2223-RC EUDAMEDFDA UDI
Description
Resolve proximal component trial, Ø23×65mm FDA UDI

Identifiers

Catalog Number
1112-2223-RC FDA UDI
Primary DI / UDI-DI
04719886901856 EUDAMEDFDA UDI
Basic UDI-DI
B-04719886901856 EUDAMED
510(k) Number
K242315 FDA UDI
FDA Product Code
MEH FDA UDI
LZO FDA UDI
KWY FDA UDI
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Patella prosthesis trial FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3390 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Resolve Modular Revision Hip Stem by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K242315 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
United Orthopedic Corp.

Sources (2)

  • FDA UDI 7c778796-f5fc-426d-915f-843b8ee85849 36 fields · synced Oct 7, 2026
  • EUDAMED 18520383-a692-4dc7-b033-e97e80f1a1b6 61 fields · synced Jul 8, 2026