← Back to catalogue

Corail

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
CORAIL FDA UDI
Generic Name
Coated femoral stem prosthesis, one-piece FDA UDI
Device Name
CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 135 DEGREES KS SIZE 8 HA COATED STANDARD NO COLLAR FDA UDI
Model / Reference
3L92507 FDA UDI
Description
CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 135 DEGREES KS SIZE 8 HA COATED STANDARD NO COLLAR FDA UDI

Identifiers

Catalog Number
3L92507 FDA UDI
Primary DI / UDI-DI
10603295168737 FDA UDI
510(k) Number
K042992 FDA UDI
K070554 FDA UDI
K190344 FDA UDI
K192946 FDA UDI
FDA Product Code
LZO FDA UDI
LWJ FDA UDI
MEH FDA UDI
GMDN Term
Coated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3360 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coated femoral stem prosthesis, one-piece

Corail by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated femoral stem prosthesis, one-piece.

Cleared under the same submission

K042992 also covers:

K070554 also covers:

K190344 also covers:

K192946 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
Depuy (ireland)

Sources (1)

  • FDA UDI e15565cb-c193-4fb9-ab13-7be0d6d3a7e0 36 fields · synced May 30, 2026