FDA Product Code
FDA Product Code MBL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3358
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics, Inc. | 2021-08-24 | Traditional | PDF ↗ |
| K201701 | R3 HA Coated Acetabular Shells | Smith & Nephew, Inc. | 2020-10-06 | Traditional | PDF ↗ |
| K182535 | R3 Anteverted Liners | Smith & Nephew, Inc. | 2018-11-19 | Special | PDF ↗ |
| K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016-12-14 | Traditional | PDF ↗ |
| K122382 | DYNASTY BIOFOAM SHELL | Wrightmedicaltechnologyinc | 2012-10-22 | Special | PDF ↗ |
| K113848 | R3 XLPE LINERS | Smith & Nephew, Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K102370 | R3 XLPE ANTEVERTED LINERS | Smith & Nephew, Inc. | 2011-01-19 | Abbreviated | PDF ↗ |
| K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | Smith & Nephew, Inc. | 2010-01-26 | Traditional | PDF ↗ |
| K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | Smith & Nephew, Inc. | 2009-11-03 | Abbreviated | PDF ↗ |
| K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2007-06-06 | Special | PDF ↗ |
| K061253 | REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2006-05-31 | Special | PDF ↗ |
| K960094 | REFLECTION DUAL DIMENSION SHELL | Smith & Nephew Richards, Inc. | 1996-03-27 | Traditional | PDF ↗ |
| K931107 | LOGYK ACETABULAR COMPONENT SYSTEM | Arthronics, Inc. | 1994-03-28 | Traditional | PDF ↗ |
Product code MBL · Class II · Orthopedic. Data: openFDA.