Data / Medical devices / Japan / Zimmer Biomet G.K.
Zimmer Biomet G.K.: FDA-registered device maker in Hiratsuka Kanagawa, Japan, 21 510(k) clearances
Zimmer Biomet G.K. is registered with the FDA (registration 3012725451) in Hiratsuka Kanagawa, Japan. It lists 46 device types. The FDA files 21 510(k) clearances under its listings, the newest dated July 28, 2017. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012725451
- Address
- 6-15 Shinmachi, Hiratsuka Kanagawa, Japan, 254-0076
- Owner or operator
- Zimmer Biomet APAC DFE (10056128)
- Roles
- Exporter to the US
- First device listed
- April 5, 2018
- Registered through
- 2027
- Brand names listed
- ANA0TOMICAL SHOULDER TM COMBINED SYSTEM, BENDER, BIOMET CEMENT; MIXER, BIOMET DEPTH; GAUGE; Gauge Biomet Depth, BIOMET FILE, BIOMET IMPACTOR, BIOMET OSTEOTOME, Bi-Metric CoCr Head/Neck Replacement Hip Stems and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2017 | K171054 | Biomet Knee Joint Replacement Prostheses | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 10, 2016 | K153657 | Vanguard XP Knee System | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 11, 2013 | K132873 | VANGUARD XP KNEE SYSTEM | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 23, 2012 | K121874 | G7 ACETABULAR SYSTEM | PBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| August 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 30, 2011 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 15, 2011 | K103404 | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM | KWT | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| January 21, 2011 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 3, 2010 | K101086 | TAPERLOC COMPLETE | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 25, 2009 | K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 15, 2009 | K082996 | BIOLOX DELTA OPTION CERAMIC HEADS | LZO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 9, 2007 | K062994 | LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 30, 2006 | K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 17, 2006 | K052089 | XR-SERIES BI-METRIC FEMORAL COMPONENTS | LPH | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| October 27, 2005 | K052685 | ORTHOPEDIC SALVAGE SYSTEM- OSS | KRO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 29, 2005 | K050441 | TAPER 2 POROUS FEMORAL STEM | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 17, 2002 | K023085 | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM | JDI | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| March 22, 2002 | K020580 | X-SERIES BI-METRIC HIP FEMORAL COMPONENTS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 30, 2000 | K003429 | MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 1, 1999 | K992058 | BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 6, 1989 | K892228 | INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM | HRS | Substantially Equivalent | Intermedics Orthopedics | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Depth
- All makers of Curette
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Updated July 28, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.