FDA.reportPublic FDA data

G7 FREEDOM

Primary DI
00880304607194
Brand
G7 FREEDOM
Company
Biomet Orthopedics, LLC
Model
31-127021
Catalog number
31-127021
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030047000FREEDOM CONSTRAINED LINERSBiomet, Inc.2003-01-23KWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304607194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304607194008803046071948803046071940880304607194

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707467Z1® Hip SystemZimmer, Inc.KWZ2026-07-29
09348215154332World Cup G-Zero Liner - Size 32ASIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154356World Cup G-Zero Liner - Size 36BSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154363World Cup G-Zero Liner - Size 36CSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154370World Cup G-Zero Liner - Size 36DSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
10885862013767NAExactech, Inc.KWZ2022-07-28
10885862142627NAExactech, Inc.KWZ2022-07-28
00885556321942REDAPTSmith & Nephew, Inc.KWZ2016-02-24
00885556321393REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321492REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321591REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321690REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321744REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321843REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00880304474185Arcos® Modular Revision Hip SystemBiomet Orthopedics, LLCKWZ2015-10-24
00880304474246Arcos® Modular Revision Hip SystemBiomet Orthopedics, LLCKWZ2015-10-24
00880304539259Arcos® Modular Revision Hip SystemBiomet Orthopedics, LLCKWZ2015-10-24
10603295218289S-ROMDEPUY (IRELAND)KWZ2015-09-24
10603295218470S-ROMDEPUY (IRELAND)KWZ2015-09-24
10603295218487S-ROMDEPUY (IRELAND)KWZ2015-09-24
10603295218951S-ROMDEPUY (IRELAND)KWZ2015-09-24
07613153071273RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWZ2015-09-24