MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class II
FDA Device Classification
Classification Details
- Product Code
- MBL
- Device Class
- Class II
- Regulation Number
- 888.3358
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K201157 | microport orthopedics | Prime BIOFOAM® Multi-Hole Shells | August 24, 2021 |
| K201701 | smith and nephew | R3 HA Coated Acetabular Shells | October 6, 2020 |
| K182535 | smith and nephew | R3 Anteverted Liners | November 19, 2018 |
| K161233 | smith and nephew | OXINIUM DH Fermoral Heads | December 14, 2016 |
| K122382 | wrightmedicaltechnologyinc | DYNASTY BIOFOAM SHELL | October 22, 2012 |
| K113848 | smith and nephew | R3 XLPE LINERS | April 27, 2012 |
| K102370 | smith and nephew | R3 XLPE ANTEVERTED LINERS | January 19, 2011 |
| K093363 | smith and nephew | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | January 26, 2010 |
| K092386 | smith and nephew | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | November 3, 2009 |
| K070756 | smith and nephew | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | June 6, 2007 |
| K061253 | smith and nephew | REFLECTION 3 ACETABULAR SYSTEM | May 31, 2006 |
| K960094 | smith and nephew richards | REFLECTION DUAL DIMENSION SHELL | March 27, 1996 |
| K931107 | arthronics | LOGYK ACETABULAR COMPONENT SYSTEM | March 28, 1994 |