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
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

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
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
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
07613153071396RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071594RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWZ2015-09-24