FDA.reportPublic FDA data

Aequalis™ Adjustable Reversed

Primary DI
00846832068203
Brand
Aequalis™ Adjustable Reversed
Company
TORNIER, INC.
Model
6121310
Catalog number
6121310
Published
2015-10-09
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120739000AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEMTornier, Inc.2012-07-05PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832068203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832068203008468320682038468320682030846832068203

GMDN Terms#

Term, Definition table
TermDefinition
Coated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length110Millimeter
Outer Diameter13Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846832085675TORNIER PERFORM™ REVERSEDDWJ1017304DWJ10173042022-01-05
00846832085682TORNIER PERFORM™ REVERSEDDWJ1017305DWJ10173052022-01-05
00846832085699TORNIER PERFORM™ REVERSEDDWJ1017306DWJ10173062022-01-05
00846832085705TORNIER PERFORM™ REVERSEDDWJ1017307DWJ10173072022-01-05
00846832085743TORNIER PERFORM™ REVERSEDDWJ1017204DWJ10172042022-01-05
00846832085750TORNIER PERFORM™ REVERSEDDWJ1017205DWJ10172052022-01-05
00846832085767TORNIER PERFORM™ REVERSEDDWJ1017206DWJ10172062022-01-05
00846832085774TORNIER PERFORM™ REVERSEDDWJ1017207DWJ10172072022-01-05
00846832085781TORNIER PERFORM™ REVERSEDDWJ1017701DWJ10177012022-01-05
00846832085798TORNIER PERFORM™ REVERSEDDWJ1017702DWJ10177022022-01-05
00846832085804TORNIER PERFORM™ REVERSEDDWJ1017703DWJ10177032022-01-05
00846832085811TORNIER PERFORM™ REVERSEDDWJ1017601DWJ10176012022-01-05
00846832085828TORNIER PERFORM™ REVERSEDDWJ1017602DWJ10176022022-01-05
00846832085835TORNIER PERFORM™ REVERSEDDWJ1017603DWJ10176032022-01-05
00846832092086Tornier Perform® Reversed Augmented GlenoidDWJ513DWJ5132022-05-10
00846832092093Tornier Perform® Reversed Augmented GlenoidDWJ503DWJ5032022-05-10
00846832092109Tornier Perform® Reversed Augmented GlenoidDWJ505DWJ5052022-05-10
00846832092123Tornier Perform® Reversed Augmented GlenoidDWJ502DWJ5022022-05-10
00846832092130Tornier Perform® Reversed Augmented GlenoidDWJ514DWJ5142022-05-10
00846832092147Tornier Perform® Reversed Augmented GlenoidDWJ515DWJ5152022-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795824Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795831Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795848Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795855Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795879Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00889024707047Signature ONE Software PackageOrthosoft IncHSD2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-13
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08