510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Osteomed

Addison, TX, US

OSTEOMED appears in FDA device records in Addison, TX. FDA records list 73 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
73
PMA records
0
Recall records
16
Registered establishments
1

510(k) clearance history

Showing 50 of 73

FDA records hold 73 510(k) clearances for Osteomed between 1991 and 2022. The busiest year on record is 2002, with 6. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Osteomed, by decision year
YearClearances
19912
19933
19943
19953
19962
19972
19981
19991
20012
20026
20035
20042
20051
20064
20073
20083
20092
20102
20112
20123
20135
20143
20154
20161
20173
20181
20202
20211
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212570OsteoPlan SystemDZJSubstantially Equivalent
K203479ExtremiLOCK Lateral Ankle Fusion PlatesHRSSubstantially Equivalent
K202105OsteoMed ExtremiFix Mini & Small System TrayKCTSubstantially Equivalent
K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWCSubstantially Equivalent
K173391OsteoMed QuickFix Hybrid MMF Sterilization TrayKCTSubstantially Equivalent
K162542OsteoMed PINNACLE DriverHBESubstantially Equivalent
K163303OsteoMed ExtremiFix Mid and Large Screw SystemHWCSubstantially Equivalent
K162544OsteoMed PINNACLE DriverKMWSubstantially Equivalent
K161041OsteoMed ExtremiLOCK Wrist Plating SystemHRSSubstantially Equivalent
K152145OsteoMed ExtremiLOCK Wrist Plating SystemHRSSubstantially Equivalent
K151195OsteoMed IMF ScrewDZLSubstantially Equivalent
K151021OsteoMed Cannulated Screw SystemHWCSubstantially Equivalent
K143338Argulated Locking PlatesJEYSubstantially Equivalent
K140978OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEMJEYSubstantially Equivalent
K140283OSTEOMED EXTREMIFUSE SYSTEMHWCSubstantially Equivalent
K133691EXTRIMILOCK ANKLE PLATING SYSTEMHRSSubstantially Equivalent
K131851OSTEOMED NEURO RONGEURHAESubstantially Equivalent
K1334371ST MTP PLATEHRSSubstantially Equivalent
K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMHRSSubstantially Equivalent
K123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORPBJSubstantially Equivalent
K130412OSTEOMED EXTREMIFUSE SYSTEMHWCSubstantially Equivalent
K123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMMAXSubstantially Equivalent
K121304OSTEOMED CRANIAL DISTRACTION SYSTEMPBJSubstantially Equivalent
K120015OSTEOMED WRIST PLATING SYSTEMHRSSubstantially Equivalent
K111419OSTEOMED HAND FUSION SYSTEMHRSSubstantially Equivalent
K111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEMGWOSubstantially Equivalent
K102438PRIMALOK FACET FIXATION SYSTEMMRWSubstantially Equivalent
K100354PRIMAL OK INTERSPINOUS FUSION SYSTEMKWPSubstantially Equivalent
K091614OSTEOMED FOOT PLATING SYSTEMHRSSubstantially Equivalent
K090522OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEMHRSSubstantially Equivalent
K081876OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATINGKWDSubstantially Equivalent
K080694OSTEOMED MODULAR LOCKING FIXATION SYSTEMJEYSubstantially Equivalent
K073065OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEMKWDSubstantially Equivalent
K071105OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEMHRSSubstantially Equivalent
K063792OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEMMQNSubstantially Equivalent
K063298OSTEOMED HEADLESS CANNULATED SCREW SYSTEMHWCSubstantially Equivalent
K062851OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDEDMQNSubstantially Equivalent
K062863OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEMHWCSubstantially Equivalent
K060536OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEMKWDSubstantially Equivalent
K051798OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEMDZESubstantially Equivalent
K043434OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEMMQNSubstantially Equivalent
K031701OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEMNEISubstantially Equivalent
K031936OSTEOMED ORTHODONTIC SCREW SYSTEMDZESubstantially Equivalent
K031708OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEMMQNSubstantially Equivalent
K030790OSTEOMED ALVEOLAR DISTRACTION SYSTEMMQNSubstantially Equivalent
K031155OSTEOMED SUBTALAR IMPLANT SYSTEMHWCSubstantially Equivalent
K030448OSTEOMED 2.0 LOCKING PLATES AND SCREWSJEYSubstantially Equivalent
K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMGXNSubstantially Equivalent
K022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMKWHSubstantially Equivalent
K022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMKWHSubstantially Equivalent

Registered establishments

FDA registered establishments for Osteomed, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20277542027754OSTEOMED3885 Arapaho Rd, ADDISON, TX 75001 US2026and 49 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2108-2023REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, SterileScrews for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.Class IIOpen, Classified
Z-2107-2023REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, SterileScrews for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.Class IIOpen, Classified
Z-0335-2022OsteoMed 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 OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.Class IIOpen, Classified
Z-2191-2020OSTEOVATION 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2190-2020OSTEOVATION 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2189-2020OSTEOVATION 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2188-2020OSTEOVATION 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2187-2020OSTEOVATION 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2186-2020OSTEOVATIONEX 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2185-2020OSTEOVATIONEX 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2184-2020OSTEOVATION 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2183-2020OSTEOVATION 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2182-2020OSTEOVATIONEX 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2181-2020OSTEOVATIONEX 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-2180-2020OSTEOVATIONEX 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.Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.Class IITerminated
Z-0008-2012OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001Two of the Implant Driver Assembly tips were reported to break during surgery.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain