Product code MBL— Orthopedic
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
- Classification name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code MBL
FDA has cleared devices under product code MBL between 1994 and 2021, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2021
- 2020
- 2018
- 2016
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 1996
- 1994
Top applicants under product code MBL
Adverse events under product code MBL
product code MBL- Injury
- 439
- Total
- 439
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MBL
- K201157 — Prime BIOFOAM® Multi-Hole Shells
- K201701 — R3 HA Coated Acetabular Shells
- K182535 — R3 Anteverted Liners
- K161233 — OXINIUM DH Fermoral Heads
- K122382 — DYNASTY BIOFOAM SHELL
- K113848 — R3 XLPE LINERS
- K102370 — R3 XLPE ANTEVERTED LINERS
- K093363 — COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
- K092386 — R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
- K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
- K061253 — REFLECTION 3 ACETABULAR SYSTEM
- K960094 — REFLECTION DUAL DIMENSION SHELL
- K931107 — LOGYK ACETABULAR COMPONENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.