JDL — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class III
FDA product code JDL covers "Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)", a Class III medical device regulated under 21 CFR 888.3320. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K934440 | howmedica | PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES | February 22, 1994 |
| K930833 | howmedica | PCA(R) SOLID BACK ACETABULA SHELL | 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 |