FDA.reportPublic FDA data

M2A - MODULAR HEAD HIP SYSTEM

Primary DI
00880304647268
Brand
M2A - MODULAR HEAD HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
BH400338
Catalog number
BH400338
Published
2020-03-25
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
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)Orthopedic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061423000M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADSBiomet Manufacturing Corp2006-07-27KWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304647268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304647268008803046472688803046472680880304647268

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
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
09348215185428Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185435Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185442Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185459Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185466Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185473Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185480Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185497Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185503Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185510Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185527Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185534Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185664Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185671Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185688Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185695Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185701Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185718Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185725Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185732Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185749Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185756Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185763Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185770Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
00880304002296RingLoc® Hip SystemBiomet Orthopedics, LLCKWA2019-11-16
00880304005785RingLoc® Hip SystemBiomet Orthopedics, LLCKWA2019-11-16
00880304008694RingLoc® Hip SystemBiomet Orthopedics, LLCKWA2019-11-16
00880304008700RingLoc® Hip SystemBiomet Orthopedics, LLCKWA2019-11-16
00880304185630RingLoc® Hip SystemBiomet Orthopedics, LLCKWA2019-11-16
00880304185708RingLoc® Hip SystemBiomet Orthopedics, LLCKWA2019-11-16