FDA.reportPublic FDA data

Tandem

Primary DI
03596010079848
Brand
Tandem
Company
Smith & Nephew, Inc.
Model
126655
Catalog number
126655
Device description
TANDEM UNIPOLAR HEAD 55MM
Published
2015-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZYProsthesis, hip, hemi-, femoral, metal ball

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZYProsthesis, Hip, Hemi-, Femoral, Metal BallOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211176000
K231448000
K896580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH
K231448000TANDEM Hip SystemSmith & Nephew, Inc.2023-07-19LZY
K896580000UNI-POLAR HEADRichards Medical Co., Inc.1990-02-15LZY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010079848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010079848035960100798483596010079848

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+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
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

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Primary DI, Brand, Company table
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07630040719988AMIStem-PMedacta International SALZY2021-10-22
07630040719995AMIStem-PMedacta International SALZY2021-10-22
07630040720007AMIStem-PMedacta International SALZY2021-10-22
07630040720014AMIStem-PMedacta International SALZY2021-10-22
07630040720021AMIStem-PMedacta International SALZY2021-10-22
07630040720038AMIStem-PMedacta International SALZY2021-10-22
07630040720045AMIStem-PMedacta International SALZY2021-10-22
07630040720052AMIStem-PMedacta International SALZY2021-10-22
07630040720069AMIStem-PMedacta International SALZY2021-10-22
07630040720076AMIStem-PMedacta International SALZY2021-10-22
07630040720083AMIStem-PMedacta International SALZY2021-10-22
07630040720090AMIStem-PMedacta International SALZY2021-10-22
07630040720106AMIStem-PMedacta International SALZY2021-10-22
07630040720113AMIStem-PMedacta International SALZY2021-10-22
07630040720120AMIStem-PMedacta International SALZY2021-10-22
07630040720137AMIStem-PMedacta International SALZY2021-10-22
07630040720144AMIStem-PMedacta International SALZY2021-10-22
07630040720151AMIStem-PMedacta International SALZY2021-10-22
07630040720168AMIStem-PMedacta International SALZY2021-10-22
07630040720175AMIStem-PMedacta International SALZY2021-10-22
07630040720182AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720199AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720205AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720212AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720229AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720236AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720243AMIStem-P CollaredMedacta International SALZY2021-10-22