First Choice Modular Ulnar Head Implant

Primary DI
00885556826232
Brand
First Choice Modular Ulnar Head Implant
Company
Smith & Nephew, Inc.
Model
MUH-600-S45M-WW
Catalog number
MUH-600-S45M-WW
Device description
MUH STEM SZ. 4.5 M
Published
2022-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXEProsthesis, wrist, hemi-, ulnar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXEProsthesis, Wrist, Hemi-, UlnarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052137000
K112481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052137000ASCENSION MUHAscension Orthopedics, Inc.2005-11-03KXE
K112481000FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension Orthopedic2012-04-09KXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556826232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556826232008855568262328855568262320885556826232

GMDN Terms#

Term, Definition table
TermDefinition
Wrist ulna-head prosthesisA sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30
00885556236949STRUCSURE7178057178052016-04-08
00885556236994STRUCSURE7178087178082016-04-08
00885556237045STRUCSURE7178167178162016-04-08
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556826621First Choice DRUJ and MUHSmith & Nephew, Inc.KXE2023-06-16
00885556826461First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826478First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826485First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826492First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826508First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826515First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826522First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826539First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826546First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826553First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826560First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826577First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826584First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826591First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826607First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826614First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826195First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826201First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826218First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826225First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826249First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826256First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826263First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826270First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826287First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826294First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826300First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
B013DRUJB10200NAAPTIS MEDICAL, LLCKXE2021-08-27
B013DRUJB200NAAPTIS MEDICAL, LLCKXE2021-08-27