JDL — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class III
FDA Device Classification
Classification Details
- Product Code
- JDL
- Device Class
- Class III
- Regulation Number
- 888.3320
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K073499 | zimmer | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | August 7, 2008 |
| K070785 | wrightmedicaltechnologyinc | DYNASTY ACETABULAR SYSTEM | July 11, 2007 |
| K061844 | wrightmedicaltechnologyinc | DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER | December 6, 2006 |
| K051995 | wrightmedicaltechnologyinc | PROFEMUR RENAISSANCE HIP STEM | August 22, 2005 |
| K051348 | wrightmedicaltechnologyinc | CONSERVE TOTAL FEMORAL HEAD | August 19, 2005 |
| K042841 | biomet | M2A/C2A ACETABULAR SYSTEM | December 21, 2004 |
| K041586 | wrightmedicaltechnologyinc | PROFEMUR S HIP STEM | July 9, 2004 |
| K041114 | wrightmedicaltechnologyinc | PROFEMUR TAPERED HIP STEM | May 28, 2004 |
| K004043 | wrightmedicaltechnologyinc | METAL TRANSCEND ARTICULATION SYSTEM | July 13, 2001 |
| K950542 | encore orthopedics | METAL BACKED ACETABULAR COMPONENT | May 25, 1995 |
| K944769 | johnson and johnson professionals | P.F.C. APICAL PLUG | December 8, 1994 |
| K942809 | osteonics | ACETABULAR DOME HOLE PLUGS | September 20, 1994 |
| K931676 | joint medical products | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG | May 18, 1994 |
| K930833 | howmedica | PCA(R) SOLID BACK ACETABULA SHELL | February 22, 1994 |
| K934440 | howmedica | PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES | February 22, 1994 |
| K935669 | regulatory and marketing services | SYRIGENE PRE-FILLED SYRINGE | February 18, 1994 |
| K922561 | u.s. medical products | CONSENSUS(TM) TOTAL HIP SYSTEM | July 21, 1993 |
| K915529 | implantology | FPC/SFPC/RFPC ACETABULAR COMPONENT | July 13, 1993 |
| K915527 | implantology | CPS ACETABULAR COMPONENT | June 24, 1993 |
| K922861 | osteo technology | BIOMETRIC SCREW FIXATION CUP | May 12, 1993 |