Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- QHGDefect Measurement Tool2Product Code
- NQOProsthesis, Spinous Process Spacer/Plate3Product Code
- HTMStimulator, Osteogenesis, Electric, Battery-Operated, Invasive3Product Code
- HWFProsthesis, Ligament3Product Code
- LMLLigaments And Tendons, Synthetic3Product Code
- LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses3Product Code
- LOEStimulator, Invasive Bone Growth3Product Code
- LOFStimulator, Bone Growth, Non-Invasive3Product Code
- P210016ManaFuseAPPRPMA Approval
- P230025Xstim Spine Fusion StimulatorAPPRPMA Approval
- P210035AccelStimTM Bone Growth StimulatorAPPRPMA Approval
- P190030ActaStim-S Spine Fusion StimulatorAPPRPMA Approval
- P030034CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEMAPPRPMA Approval
- P900009SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2AAPPRPMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATORAPPRPMA Approval
- P850007PHYSIO-STIM(TM) I & II MODEL 6000 & 7000APPRPMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATORAPPRPMA Approval
- K822155ETHICON TEMPORARY CARDIAC PACING WIRE3Cleared 510(K)
- P900009Exogen Ultrasound Bone Healing System3PMA Approval
- P850022Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys3PMA Approval
- P030034CervicalStim3PMA Approval
- P850007PhysioStim and SpinalStim3PMA Approval
- P910066Bone Growth Stimulators3PMA Approval
- P850007SpinalStim3PMA Approval
- P030034CervicalStim3PMA Approval
- P850007PhysioStim and SpinalStim3PMA Approval
- P850007PhysioStim/SpinalStim3PMA Approval
- P030034CervicalStim3PMA Approval
- P030034CervicalStim3PMA Approval
- P850007PhysioStim, SpinalStim3PMA Approval
- P910066OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators3PMA Approval
- P900009EXOGEN Ultrasound Bone Healing System3PMA Approval
- P850022Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System3PMA Approval
- P790002Biomet EBI Bone Healing System3PMA Approval
- P030034CervicalStim3PMA Approval
- P850007PhysioStim and SpinalStim3PMA Approval
- P850007Physio-Stim3PMA Approval
- P900009EXOGEN Ultrasound Bone Healing System3PMA Approval
- P030034CervicalStim3PMA Approval
- P850007SpinalStim3PMA Approval
- P900009EXOGEN ULTRASOUND BONE HEALING SYSTEM3PMA Approval
- P850022BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM3PMA Approval
- P790002BIOMET EBI BONE HEALING SYSTEM3PMA Approval
- P850007Spinal-Stim3PMA Approval
- P030034Cervical-Stim3PMA Approval
- P790002BIO OSTEOGEN SYSTEM 2043PMA Approval
- P910066OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS3PMA Approval
- P790002BIOMET EBI BONE HEALING SYSTEM3PMA Approval
- P850022BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM3PMA Approval
- P850022BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM3PMA Approval
- P790002BIOMET EBI BONE HEALING SYSTEM3PMA Approval
- P850022BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR3PMA Approval
- P030034CERVICAL-STIM3PMA Approval
- P850007PHYSIO-STIM AND SPINAL-STIM3PMA Approval
- P910066OL1000, OL1000 SC, SPINALOGIC3PMA Approval
- P850022THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO3PMA Approval
- P850022THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO3PMA Approval
- P850007PHYSIO-STIM AND SPINAL-STIM3PMA Approval
- P030034CERVICAL-STIM3PMA Approval
- P790002BIOMET EBI BONE HEALING SYSTEM3PMA Approval
- P850022BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM3PMA Approval
- P790002BIOMET EBI BONE HEALING3PMA Approval
- P850022BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR3PMA Approval
- P850022BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM; BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM3PMA Approval
- P790002THE BIOMET EBI BONE HEALING SYSTEM3PMA Approval
- P790002BIOMET EBI BONE HEALING SYSTEM3PMA Approval
- P790002BIOMET BHS-MINI3PMA Approval
- P910066OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS3PMA Approval
- P030034CERVICAL-STIM3PMA Approval
- P850007PHYSIO-STIM & SPINAL-STIM3PMA Approval
- P790002BIO OSTEOGEN SYSTEM3PMA Approval
- P850022BIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM3PMA Approval
- P790002BIOMET EBI BONE HEALING SYSTEM3PMA Approval
- P030034CERVICAL-STIM CERVICAL FUSION SYSTEM3PMA Approval
- P850007SPINAL-STIM SPINAL FUSION SYSTEM3PMA Approval
- P030034CERVICAL-STIM3PMA Approval
- P850007PHYSIO-STIM/SPINAL-STIM3PMA Approval
- P850022ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM3PMA Approval
- P030034CERVICAL-STIM3PMA Approval
- P850007PHYSIO-STIM AND SPINAL STIM3PMA Approval
- P850007PHYSIO-STIM & SPINAL-STIM3PMA Approval
- P030034CERVICAL STIM3PMA Approval
- P910066SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS3PMA Approval
- P790002BIOMET BHS- MINI3PMA Approval
- P910066OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE3PMA Approval
- P910066SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS3PMA Approval
- P910066OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR3PMA Approval
- P850022ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM3PMA Approval
- P790002EBI BONE HEALING SYSTEM3PMA Approval
- P910066SPINALOGIC 1000 BONE GROWTH STIMULATOR3PMA Approval
- P030034CERVICAL-STIM CERVICAL FUSION SYSTEM3PMA Approval
- P910066OL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS3PMA Approval
- P850007PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 22123PMA Approval
- P030034CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM3PMA Approval
- P910066OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS3PMA Approval
- P850022BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR3PMA Approval
- P910066OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS3PMA Approval
- P850022BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR3PMA Approval
- P790002EBI BONE HEALING SYSTEM - MODEL 20013PMA Approval
- P850022BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR3PMA Approval
- P910066OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS3PMA Approval
- P850007PHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR3PMA Approval
- P910066SPINALOGIC BONE GROWTH STIMULATOR3PMA Approval
- P850007PHYSIO-STIM BONE GROWTH STIMULATOR3PMA Approval
- P910066ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR3PMA Approval
- P850007PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS3PMA Approval
- P790002EBI BONE HEALING SYSTEM-MODEL 10263PMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR3PMA Approval
- P850022SPINALPAK(R) STIMULATOR3PMA Approval
- P850022ORTHOPAK BONE GROWTH STIMULATOR3PMA Approval
- P910066ORTHOLOGIC 1000 BONE GROWTH STIMULATOR/PATIENT REGISTRY MARKETING BROCHURE3PMA Approval
- P790002EBI BONE HEALING SYSTEM3PMA Approval
- P850007SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM3PMA Approval
- P910066ORTHOLOGIC 1000 SC3PMA Approval
- P850007PHYSIO-STIM BONE GROWTH STIMULATOR3PMA Approval
- P850007PHYSIO-STIM BONE GROWTH STIMULATOR3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR3PMA Approval
- P850022ORTHOPAK II BONE GROWTH STIMULATOR3PMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR3PMA Approval
- P850007SPINAL-STIM LITE SPINAL FUSION SYSTEM3PMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P850007SPINAL-STIM LITE SPINAL FUSION SYSTEM3PMA Approval
- P910066ORTHOLOGIC 1000 BONE GROWTH STIMULATOR3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR3PMA Approval
- P850007PHYSIO-STIM LITE BONE GROWTH STIMULATOR3PMA Approval
- P850007SPINAL-STIM(R) MODEL 8212C3PMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR3PMA Approval
- P850007SPINAL-STIM(R)3PMA Approval
- P850007SPINAL-STIM(R)3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P900009SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A3PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR3PMA Approval
- P850007PHYSIO-STIM(R)3PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P850007PHYSIO-STIM(TM)3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)-MODEL 1233PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)-MODEL 10263PMA Approval
- P850007PHYSIO-STIM(TM)3PMA Approval
- P850007PHYSIO-STIM(R)3PMA Approval
- P850007MODEL 8500 AME BONE GROWTH STIMULATOR3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P850007AME BONE GROWTH STIMULATOR3PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P850007AME BONE GROWTH STIMULATOR3PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P850007AME BONE GROWTH STIMULATOR3PMA Approval
- P850007AME BONE GROWTH STIMULATOR3PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P850007AME BONE GROWTH STIMULATOR3PMA Approval
- P790002EBI BONE HEALING SYSTEM MODEL 10203PMA Approval
- P790002EBI BONE HEALING SYSTEM(R)3PMA Approval
- P850007AME BONE GROWTH STIMULATOR3PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P850007AME BONE GROWTH STIMULATOR3PMA Approval
- P850007PHYSIO-STIM(TM) I & II MODEL 6000 & 70003PMA Approval
- P850022ORTHOPAK(R) BONE GROWTH STIMULATOR3PMA Approval
- P790002BIO OSTEOGEN SYSTEM 2043PMA Approval
- P790002BIO OSTEOGEN SYSTEM 2043PMA Approval
- P790002BIO OSTEOGEN SYSTEM 2043PMA Approval
- P790002BIO OSTEOGEN SYSTEM 2043PMA Approval
- P790002BIO OSTEOGEN SYSTEM 2043PMA Approval
- P790002BIO OSTEOGEN SYSTEM 2043PMA Approval
- LPFProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented3Product Code
- LPQStimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep3Product Code
- LWAProsthesis, Ligament, Ptfe3Product Code
- LXCMonitor, Pressure, IntracompartmentalUProduct Code
- LXYProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer3Product Code
- LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedUProduct Code
- MBDProsthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer3Product Code
- MBJFastener, Fixation, Biodegradable, Hard Tissue3Product Code
- MBSFiller, Bone Void, Non-Osteoinduction3Product Code
- MCVSpinal Pedicle Screw, Fixation, Appliance System3Product Code
- MDIProsthesis, Rib ReplacementUProduct Code
- MJOProsthesis, Intervertebral Disc3Product Code
- MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented3Product Code
- MOZAcid, Hyaluronic, Intraarticular3Product Code
- MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisFProduct Code
- MPWFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction3Product Code
- MQOProsthetic Disc Nucleus DeviceNProduct Code
- MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3Product Code
- MRWSystem, Facet Screw Spinal DeviceUProduct Code
- NBNGenerator, Shock-Wave, For Pain Relief3Product Code
- NCOImplant, Cartilage, For Articular Cartilage Repair3Product Code
- NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis3Product Code
- NEKFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction3Product Code
- NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NOXFiller, Bone Void, Synthetic Peptide3Product Code
- NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NTGProsthesis, Ankle, Uncemented, Non-Constrained3Product Code
- NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, LumbarUProduct Code
- NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing3Product Code
- OJZFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - HdeFProduct Code
- OKDFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone NonunionFProduct Code
- OMEExtracorporeal Shock Wave Treatment3Product Code
- OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisFProduct Code
- OVOProsthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation3Product Code
- OYRFiller, Bone Void, Recombinant Platelet-Derived Growth FactorNProduct Code
- PBUBone Void Filler, SyringeNProduct Code
- PFMHemibridge SystemNProduct Code
- PGMGrowing Rod SystemUProduct Code
- PGNGrowing Rod System- Magnetic ActuationUProduct Code
- PIXElbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented ProsthesisNProduct Code
- PJYOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees3Product Code
- PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant3Product Code
- PWGSpinal Fixation SystemNProduct Code
- QCGFiller, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow LesionsNProduct Code
- QESReherniation Reduction Device3Product Code
- QGPPosterior Ratcheting Rod SystemNProduct Code
- QHPVertebral Body Tethering SystemNProduct Code
- QNNTalus SpacerFProduct Code
- QRRFiller, Bone Void, Calcium Compound Containing Gentamicin2Product Code
- QJDAbsorbable Metallic Bone Fixation Fastener2Product Code
- QKWShoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis2Product Code
- QVVMedial Knee Implanted Shock Absorber2Product Code
- QWLIntraoperative Surgical Angle Measurement Tool2Product Code
- QRUImplant, Resorbable, For Articular Osteochondral Repair3Product Code
- QWKProsthesis, Posterior Spinal Elements3Product Code
- QYQProsthesis, Total Talus Replacement With Soft Tissue Attachment Sites, MetalFProduct Code
- QZOWearable Vibration Device For Orthopedic Use2Product Code
- QZYSpinal Fusion Device With Quaternary Ammonium Compound Coating2Product Code
- QZZLimb And Joint Salvage Device With Coating For Bacteria Reduction2Product Code
- QVLAbsorbable Gel For Intraoperative Use In Spine Surgery2Product Code
- SFAProsthesis, Finger, Semi-Constrained, Metal/Polymer3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Biomet EBI Bone Healing System
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- EBI, LLC
- Trade Name
- BIO OSTEOGEN SYSTEM 204
- Generic Name
- Stimulator, bone growth, non-invasive
- Decision Date
- 11/6/1979
- Days to Decision
- 295 days
- Decision Code
- APPR
- FDA Decision
- Approval