FDA.reportPublic FDA data

BIOCERAM AZUL HEAD

Primary DI
04547898491207
Brand
BIOCERAM AZUL HEAD
Company
KYOCERA CORPORATION
Model
GMH04-400060
Catalog number
GMH04-400060
Device description
AZUL HEAD 28 +7
Published
2025-01-29
Public version status
New
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
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547898491207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547898491207045478984912074547898491207

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
909-557-2360kmti.info@kyocera.com

Regulatory Flags#

DUNS number
690557624
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547898491160BIOCERAM AZUL HEADGMH04-400051GMH04-4000512025-01-29
04547898491177BIOCERAM AZUL HEADGMH04-400052GMH04-4000522025-01-29
04547898491184BIOCERAM AZUL HEADGMH04-400053GMH04-4000532025-01-29
04547898491191BIOCERAM AZUL HEADGMH04-400054GMH04-4000542025-01-29
04547898777561Initia Total Hip SystemTJ51146-1TJ51146-12023-05-24
04547898777578Initia Total Hip SystemTJ51146-2TJ51146-22023-05-24
04547898777585Initia Total Hip SystemTJ51146-3TJ51146-32023-05-24
04547898439025Initia Total Hip SystemTJ51146-1TJ51146-12022-12-06
04547898439032Initia Total Hip SystemTJ51146-2TJ51146-22022-12-06
04547898439049Initia Total Hip SystemTJ51146-3TJ51146-32022-12-06
04547898438974Initia Total Hip SystemTJ51147TJ511472022-12-06
04547898440434Initia Total Hip SystemTJ51461TJ514612022-12-06
04547898438080Initia Total Hip SystemTJ42890TJ428902022-11-09
04547898438233Initia Total Hip SystemTJ51247TJ512472022-11-09
04547898432491Initia Total Hip SystemTJ39639-1TJ39639-12021-11-30
04547898432507Initia Total Hip SystemTJ39641-1TJ39641-12021-11-30
04547898432514Initia Total Hip SystemTJ39643-1TJ39643-12021-11-30
04547898432521Initia Total Hip SystemTJ39645-1TJ39645-12021-11-30
04547898432538Initia Total Hip SystemTJ39647-1TJ39647-12021-11-30
04547898433979Initia Total Hip System21057-00-000021057-00-00002021-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
07630542788314AMIStem-PMedacta International SALZO2026-06-08
07630542788321AMIStem-PMedacta International SALZO2026-06-08
07630542788338AMIStem-PMedacta International SALZO2026-06-08
07630542788345AMIStem-PMedacta International SALZO2026-06-08
07630542788352AMIStem-PMedacta International SALZO2026-06-08
07630542788369AMIStem-PMedacta International SALZO2026-06-08
07630542788376AMIStem-PMedacta International SALZO2026-06-08
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01