MBLClass II
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
21 CFR 888.3358 / Orthopedic
MBL is the FDA product code for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, a class II device type, regulated under 21 CFR 888.3358. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- MBL
- Device name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Regulation
- 21 CFR 888.3358
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 13
- Ingested recalls
- 12
Clearances, product code MBL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1996 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code MBL| Applicant | Clearances |
|---|---|
| Smith & Nephew, Inc. | 9 |
| Arthronics, Inc. | 1 |
| Microport Orthopedics Inc. | 1 |
| Smith & Nephew Richards, Inc. | 1 |
| Wrightmedicaltechnologyinc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.