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
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442100200SignatureMaterialise NVKWZ2026-09-24
E31442100300SignatureMaterialise NVKWZ2026-09-24
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000095Triple Taper Stem Standard Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000101Triple Taper Stem High Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000118Triple Taper Stem Standard Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000125Triple Taper Stem High Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000132Triple Taper Stem Standard Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000149Triple Taper Stem High Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000156Triple Taper Stem Standard Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000163Triple Taper Stem High Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22