Company ยท US
Osteomed LP
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2022. Name variants (Inc, Corp, punctuation) are merged.
73510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 15 |
| HRS | Plate, Fixation, Bone | 12 |
| MQV | Filler, Bone Void, Calcium Compound | 12 |
| JEY | Plate, Bone | 7 |
| MQN | External Mandibular Fixator And/Or Distractor | 7 |
| DZL | Screw, Fixation, Intraosseous | 5 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 3 |
| KMW | Handpiece, Rotary Bone Cutting | 3 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 2 |
| MRW | System, Facet Screw Spinal Device | 2 |
| PBJ | Cranial Distraction System | 2 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 |
| HAE | Rongeur, Manual | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2022 | K212570 | OsteoPlan System Osteomed, LLC | DZJ |
| Feb 24, 2021 | K203479 | ExtremiLOCK Lateral Ankle Fusion Plates Osteomed | HRS |
| Oct 29, 2020 | K202105 | OsteoMed ExtremiFix Mini & Small System Tray Osteomed, LLC | KCT |
| Oct 15, 2020 | K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System Osteomed, LLC | HWC |
| May 10, 2018 | K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray Osteomed, LLC | KCT |
| May 19, 2017 | K162542 | OsteoMed PINNACLE Driver Osteomed | HBE |
| Apr 4, 2017 | K163303 | OsteoMed ExtremiFix Mid and Large Screw System Osteomed, LLC | HWC |
| Apr 4, 2017 | K162544 | OsteoMed PINNACLE Driver Osteomed | KMW |
| May 19, 2016 | K161041 | OsteoMed ExtremiLOCK Wrist Plating System Osteomed | HRS |
| Dec 21, 2015 | K152145 | OsteoMed ExtremiLOCK Wrist Plating System Osteomed | HRS |
| Sep 21, 2015 | K151195 | OsteoMed IMF Screw Osteomed | DZL |
| Jul 15, 2015 | K151021 | OsteoMed Cannulated Screw System Osteomed Corp. | HWC |
| Apr 1, 2015 | K143338 | Argulated Locking Plates Osteomed LP | JEY |
| Dec 18, 2014 | K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM Osteomed | JEY |
| Feb 28, 2014 | K140283 | OSTEOMED EXTREMIFUSE SYSTEM Osteomed | HWC |
| Feb 24, 2014 | K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM Osteomed LP | HRS |
| Dec 6, 2013 | K131851 | OSTEOMED NEURO RONGEUR Osteomed | HAE |
| Dec 2, 2013 | K133437 | 1ST MTP PLATE Osteomed | HRS |
| Jun 18, 2013 | K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM Osteomed LP | HRS |
| Jun 3, 2013 | K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR Osteomed LP | PBJ |
| May 31, 2013 | K130412 | OSTEOMED EXTREMIFUSE SYSTEM Osteomed | HWC |
| Nov 29, 2012 | K123207 | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM Osteomed LP | MAX |
| Aug 22, 2012 | K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM Osteomed | PBJ |
| Apr 24, 2012 | K120015 | OSTEOMED WRIST PLATING SYSTEM Osteomed LP | HRS |
| Oct 7, 2011 | K111419 | OSTEOMED HAND FUSION SYSTEM Osteomed LP | HRS |
| Aug 15, 2011 | K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM Osteomed LP | GWO |
| Sep 30, 2010 | K102438 | PRIMALOK FACET FIXATION SYSTEM Osteomed LP | MRW |
| Aug 17, 2010 | K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM Osteomed LP | KWP |
| Sep 10, 2009 | K091614 | OSTEOMED FOOT PLATING SYSTEM Osteomed LP | HRS |
| Jul 2, 2009 | K090522 | OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM Osteomed LP | HRS |
| Aug 1, 2008 | K081876 | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING Osteomed LP | KWD |
| May 15, 2008 | K080694 | OSTEOMED MODULAR LOCKING FIXATION SYSTEM Osteomed LP | JEY |
| Feb 21, 2008 | K073065 | OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM Osteomed LP | KWD |
| Jul 30, 2007 | K071105 | OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM Osteomed LP | HRS |
| Mar 2, 2007 | K063792 | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM Osteomed LP | MQN |
| Mar 2, 2007 | K063298 | OSTEOMED HEADLESS CANNULATED SCREW SYSTEM Osteomed LP | HWC |
| Nov 17, 2006 | K062851 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED Osteomed LP | MQN |
| Oct 31, 2006 | K062863 | OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM Osteomed LP | HWC |
| Jun 2, 2006 | K060536 | OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM Osteomed LP | KWD |
| Apr 7, 2006 | K051798 | OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM Osteomed LP | DZE |
| Feb 10, 2005 | K043434 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM Osteomed LP | MQN |
| Jul 8, 2004 | K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM Osteomed LP | NEI |
| Jan 7, 2004 | K031936 | OSTEOMED ORTHODONTIC SCREW SYSTEM Osteomed LP | DZE |
| Nov 3, 2003 | K031708 | OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM Osteomed LP | MQN |
| Sep 10, 2003 | K030790 | OSTEOMED ALVEOLAR DISTRACTION SYSTEM Osteomed LP | MQN |
| Aug 22, 2003 | K031155 | OSTEOMED SUBTALAR IMPLANT SYSTEM Osteomed LP | HWC |
| May 9, 2003 | K030448 | OSTEOMED 2.0 LOCKING PLATES AND SCREWS Osteomed LP | JEY |
| Apr 1, 2003 | K022277 | OSTEOMED CRANIAL FLAP FIXATION SYSTEM Osteomed Corp. | GXN |
| Nov 26, 2002 | K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM Osteomed Corp. | KWH |
| Nov 25, 2002 | K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM Osteomed Corp. | KWH |
Newest 50 of 73.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2023 | Osteomed, LLC REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile Open, Classified |
GWO | K111176 |
| Jul 7, 2023 | Osteomed, LLC REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile Open, Classified |
GWO | K111176 |
| Oct 28, 2021 | Osteomed, LLC OsteoMed OsteoPower Power Console:
-OsteoMed OsteoPower Power Console 2 REF 450-0021-00
-OsteoMed D-Power Control Console 2 REF 450-0021-01
-Power Control Console 2 REF ECOS-450-0021-00
-OsteoMed Os Open, Classified |
KMW | K971692 |
| May 29, 2020 | Osteomed, LLC OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051784 |
| May 29, 2020 | Osteomed, LLC OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051784 |
| May 29, 2020 | Osteomed, LLC OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051784 |
| May 29, 2020 | Osteomed, LLC OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051784 |
| May 29, 2020 | Osteomed, LLC OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051784 |
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K100986 |
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K100986 |
| May 29, 2020 | Osteomed, LLC OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051123 |
| May 29, 2020 | Osteomed, LLC OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051123 |
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051123 |
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051123 |
| May 29, 2020 | Osteomed, LLC OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. Terminated |
MQV | K051123 |
| Oct 4, 2011 | Osteomed, Lp OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001 Terminated |
MRW | K102438 |