FDA.reportPublic FDA data

M2A - MODULAR HEAD HIP SYSTEM

Primary DI
00880304647336
Brand
M2A - MODULAR HEAD HIP SYSTEM
Company
Biomet Orthopedics, LLC
Model
BH400640
Catalog number
BH400640
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
00880304647336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304647336008803046473368803046473360880304647336

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
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
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