Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- 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
- HSRUnit, Traction, Hip, Non-Powered, Non-Penetrating1Product Code
- HRRScissors, Orthopedic, Surgical1Product Code
- HRTStripper, Surgical1Product Code
- HSPSplint, Traction1Product Code
- HSQBelt, Pelvic, Traction1Product Code
- HTHProtractor1Product Code
- HTJGauge, Depth1Product Code
- HTOReamer1Product Code
- HTPFile1Product Code
- HTQBroach1Product Code
- HTSKnife, Orthopedic1Product Code
- HTTBurr, Orthopedic1Product Code
- HTWBit, Drill1Product Code
- HTXRongeur1Product Code
- HWAImpactor1Product Code
- HWBExtractor1Product Code
- HWDStarter, Bone Screw1Product Code
- HWICorkscrew1Product Code
- HWJAwl1Product Code
- HWKTrephine1Product Code
- HWLSet, Hollow Mill1Product Code
- HWNInstrument, Compression1Product Code
- HWOSkid, Bone1Product Code
- HWPPunch, Femoral Neck1Product Code
- HWQPasser1Product Code
- HWRDriver, Prosthesis1Product Code
- HWTTemplate1Product Code
- HWWCountersink1Product Code
- HWXTap, Bone1Product Code
- HXBProbe1Product Code
- HXCWrench1Product Code
- HXEFork1Product Code
- HXGTamp1Product Code
- HXIPasser, Wire, Orthopedic1Product Code
- HXJStaple Driver1Product Code
- HXKHolder, Needle; Orthopedic1Product Code
- HXNApplier, Cerclage1Product Code
- HXOPusher, Socket1Product Code
- HXPInstrument, Bending Or Contouring1Product Code
- HXQCrimper, Pin1Product Code
- HXSTwister, Wire1Product Code
- HXWBender1Product Code
- HXXScrewdriver1Product Code
- HXYBrace, Drill1Product Code
- HXZCutter, Wire1Product Code
- JDXInstrument, Surgical, Sonic And Accessory/Attachment2Product Code
- JDYEvacuator, Vapor, Cement Monomer1Product Code
- JDZMixer, Cement, For Clinical Use1Product Code
- KIHDispenser, Cement1Product Code
- KIITube, Cement Ventilation1Product Code
- KILPositioner, Socket1Product Code
- KQZComponent, Traction, Non-Invasive1Product Code
- KTZCaliper1Product Code
- LGFComponent, Cast1Product Code
- K043526SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC1Cleared 510(K)
- K973420CLINITEX CAST PADDING1Cleared 510(K)
- K973417CLINITEX STOCKINETTE1Cleared 510(K)
- K955320PROTEC COTTON PADDING BANDAGE1Cleared 510(K)
- K932507QUICK-CAST IMMOBILIZER1Cleared 510(K)
- K931672CARAPACE STERILE CAST PADDING1Cleared 510(K)
- K910274ARTIFLEX(TM)1Cleared 510(K)
- K903946COOL CAST(R)1Cleared 510(K)
- K896634CARAGLAS XTRA SYNTHETIC CASTING TAPE1Cleared 510(K)
- K883294SYNTHETIC CAST TAPE1Cleared 510(K)
- K874880COLORED CASTING TAPE CARAGLAS(TM GREEN1Cleared 510(K)
- K873722PEDESTAL WALKING HEEL PRODUCT NO. 4183-1331Cleared 510(K)
- K873717CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-1351Cleared 510(K)
- K873718CHILD WALKING HEEL PRODUCT NO. 4183-1321Cleared 510(K)
- K870404COLORED CASTING TAPE (RED AND BLUE)1Cleared 510(K)
- K864092OEC DESIGN ORTHOPEDIC CAST HEEL1Cleared 510(K)
- K861073AMERICAN ORTHOPAEDIC VACUUM 0295-2501Cleared 510(K)
- K861075AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-2021Cleared 510(K)
- K861074AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-2001Cleared 510(K)
- K854554DELTA-LITE CASTING RESIN1Cleared 510(K)
- K854341DELTA-LITE CASTING RESIN1Cleared 510(K)
- K843780VENT-A-CAST1Cleared 510(K)
- K840617MASTERFOOT CAST HEEL1Cleared 510(K)
- K833084MASTERHINGE1Cleared 510(K)
- K823819CAST TOE COVER1Cleared 510(K)
- K823394WALKING HEEL1Cleared 510(K)
- K822059SHOW'RBAG1Cleared 510(K)
- K812904STERILE ORTHOPEDIC STOCKINETTE1Cleared 510(K)
- K810110COBBLER'S CHIP SPLINTS1Cleared 510(K)
- K803141CONPHAR CAST HEELS1Cleared 510(K)
- K780283INSERTER, PLUG, BONE, LIDGE1Cleared 510(K)
- LGGInstrument, Cast Application/Removal, Manual1Product Code
- LGHInstrument, Cast Removal, Ac-Powered1Product Code
- LXHOrthopedic Manual Surgical Instrument1Product Code
- LYQAccessories, Fixation, Spinal Intervertebral Body1Product Code
- LYSBone Mill1Product Code
- LZVSystem, Cement Removal Extraction2Product Code
- OARInjector, Vertebroplasty (Does Not Contain Cement)1Product Code
- OCJSpinal Channeling Instrument, Vertebroplasty1Product Code
- QBOInstruments Designed For Press-Fit Osteochondral Implants2Product Code
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment1Product Code
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1Product Code
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment1Product Code
- LXIGuide, Drill, Ligament1Product Code
- OJHOrthopedic Tray1Product Code
- PPPDisposable Joint Aspiration/Injection Kit1Product Code
- SAMBattery-Powered Instruments Charged Through Sterile Barriers1Product Code
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MASTERHINGE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K833084
- 510(k) Type
- Traditional
- Applicant
- MARK ONE HEALTHCARE PRODUCTS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/14/1983
- Days to Decision
- 31 days