Osteomed, LLC
FDA Regulatory Profile
Osteomed, LLC appears in FDA public data with 15 recalls, 73 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2107-2023, Class II) was initiated on May 31, 2023. Its most recent 510(k) clearance was granted on February 11, 2022.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 73
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2107-2023 | Class II | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile | May 31, 2023 |
| Z-2108-2023 | Class II | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile | May 31, 2023 |
| Z-0335-2022 | Class II | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMe | October 28, 2021 |
| Z-2183-2020 | Class II | OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provid | April 2, 2020 |
| Z-2189-2020 | Class II | OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product | April 2, 2020 |
| Z-2188-2020 | Class II | OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provide | April 2, 2020 |
| Z-2186-2020 | Class II | OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provi | April 2, 2020 |
| Z-2182-2020 | Class II | OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product prov | April 2, 2020 |
| Z-2180-2020 | Class II | OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product prov | April 2, 2020 |
| Z-2184-2020 | Class II | OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provi | April 2, 2020 |
| Z-2185-2020 | Class II | OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provi | April 2, 2020 |
| Z-2190-2020 | Class II | OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product pr | April 2, 2020 |
| Z-2191-2020 | Class II | OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product pr | April 2, 2020 |
| Z-2181-2020 | Class II | OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product prov | April 2, 2020 |
| Z-2187-2020 | Class II | OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provide | April 2, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212570 | OsteoPlan System | February 11, 2022 |
| K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | February 24, 2021 |
| K202105 | OsteoMed ExtremiFix Mini & Small System Tray | October 29, 2020 |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System | October 15, 2020 |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | May 10, 2018 |
| K162542 | OsteoMed PINNACLE Driver | May 19, 2017 |
| K162544 | OsteoMed PINNACLE Driver | April 4, 2017 |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw System | April 4, 2017 |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating System | May 19, 2016 |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating System | December 21, 2015 |
| K151195 | OsteoMed IMF Screw | September 21, 2015 |
| K151021 | OsteoMed Cannulated Screw System | July 15, 2015 |
| K143338 | Argulated Locking Plates | April 1, 2015 |
| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | December 18, 2014 |
| K140283 | OSTEOMED EXTREMIFUSE SYSTEM | February 28, 2014 |
| K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | February 24, 2014 |
| K131851 | OSTEOMED NEURO RONGEUR | December 6, 2013 |
| K133437 | 1ST MTP PLATE | December 2, 2013 |
| K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM | June 18, 2013 |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | June 3, 2013 |