Omni Life Science
FDA Regulatory Profile
Omni Life Science appears in FDA public data with 7 recalls, 21 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0610-2017, Class III) was initiated on October 14, 2016. Its most recent 510(k) clearance was granted on September 25, 2019.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 21
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0610-2017 | Class III | OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock ( | October 14, 2016 |
| Z-2372-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Kn | August 9, 2012 |
| Z-2374-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Kn | August 9, 2012 |
| Z-2371-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Kn | August 9, 2012 |
| Z-2375-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Kn | August 9, 2012 |
| Z-2373-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Kn | August 9, 2012 |
| Z-2370-2012 | Class II | Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Kn | August 9, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191765 | OMNI TiN Coated Apex Knee System | September 25, 2019 |
| K152919 | OMNI Skirted Heads | March 10, 2016 |
| K131472 | APEX KNEE MODULAR TIBIA SYSTEM | October 8, 2013 |
| K112891 | APEX REVISION KNEE SYSTEMS | February 29, 2012 |
| K113242 | APEX ARC HIP STEM | January 5, 2012 |
| K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA | July 13, 2011 |
| K111193 | APEX ARC HIP STEM | June 27, 2011 |
| K111184 | APEX PS KNEE SYSTEM - PS-C INSERT | June 22, 2011 |
| K110947 | APEX K1 HIP STEM | June 16, 2011 |
| K102578 | APEX PS KNEE SYSTEM | March 25, 2011 |
| K101976 | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET | September 14, 2010 |
| K101451 | APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD | June 22, 2010 |
| K090845 | APEX ARC HIP STEM | April 7, 2010 |
| K100555 | APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK | March 29, 2010 |
| K094017 | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 | March 5, 2010 |
| K092443 | INTERFACE ACETABULAR CUP LINERS | October 23, 2009 |
| K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-6 | February 18, 2009 |
| K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] | May 23, 2008 |
| K073150 | APEX-LNK POLY ACETABULAR CUP LINERS | February 27, 2008 |
| K060072 | MONOBLOCK PRESS-FIT HIP STEM | August 24, 2006 |