MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class II
FDA product code MBL covers "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous", a Class II medical device regulated under 21 CFR 888.3358. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 13 recent 510(k) clearances have been granted under this product code.
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 |