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
- 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
- LGGInstrument, Cast Application/Removal, Manual1Product Code
- LGHInstrument, Cast Removal, Ac-Powered1Product Code
- LXHOrthopedic Manual Surgical Instrument1Product Code
- K192873SX-One MicroKnife1Cleared 510(K)
- K140414IMBIBE NEEDLE1Cleared 510(K)
- K101609SELF RETAINING SOFT TISSUE RETRACTOR1Cleared 510(K)
- K001507MICROPERFORATION INSTRUMENT1Cleared 510(K)
- K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM1Cleared 510(K)
- K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY1Cleared 510(K)
- K944188SPINAL MARKER1Cleared 510(K)
- K941896STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR1Cleared 510(K)
- K941711HYPERFLEX FLEXIBLE GUIDEWIRES1Cleared 510(K)
- K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH1Cleared 510(K)
- K933772PUNCH SURGICAL1Cleared 510(K)
- K933242SOFAMOR ORTHOPAEDIC INSTRUMENTS1Cleared 510(K)
- K934260BARRIER BONE WAX APPLICATOR1Cleared 510(K)
- K931846BIO-PREP1Cleared 510(K)
- K930028CALMPS: BONE, MASTIN, LEWIN, BRAND1Cleared 510(K)
- K921402SURGICAL INSTRUMENT, DISPOSABLE1Cleared 510(K)
- K921645AMSEN SPINE IMPACTOR INSTRUMENTS1Cleared 510(K)
- K921644AMSEN HOCKEY STICK CHISEL1Cleared 510(K)
- K921643AMSEN POSTERIOR DISC EVACUATOR1Cleared 510(K)
- K921642AMSEN DOUBLE-ENDED FORAMINAL PROBE1Cleared 510(K)
- K901521OSTEOTOMES OF VARIOUS TYPES1Cleared 510(K)
- K901511CHISEL, BONE, SURGICAL1Cleared 510(K)
- K901420VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 81Cleared 510(K)
- K901289RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS1Cleared 510(K)
- K902819LAMINECTOMY ROGEUR1Cleared 510(K)
- K903257DRIVER/EXTRACTOR1Cleared 510(K)
- K903270T-HANDLE HEX WRENCH1Cleared 510(K)
- K903247ADJUSTABLE ANGLE GUIDE1Cleared 510(K)
- K895172KRONNER SACRAL PIN GUIDE1Cleared 510(K)
- K891903COHN TARGETEER1Cleared 510(K)
- K890162EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD1Cleared 510(K)
- K890163AUSTIN MOORE HALLOW CHISEL1Cleared 510(K)
- K890164HUDSON BRACE W/BURRS1Cleared 510(K)
- K890166RONGUER-ORTHOPEDIC1Cleared 510(K)
- K890168RETRACTOR, SELF-RETAINING1Cleared 510(K)
- K890156IMPACTOR FOR FEMORAL HEAD1Cleared 510(K)
- K890158RETRACTORS1Cleared 510(K)
- K890161THOMPSON TYPE RASP W/TOMMY BAR1Cleared 510(K)
- K890157FORCEPS1Cleared 510(K)
- K890160GOUGES FOR FEMORAL HEADS1Cleared 510(K)
- K883694TENSIOMETER1Cleared 510(K)
- K882077MICRODISCECTOMY CURRETTES1Cleared 510(K)
- K882069SPINAL DISTRACTORS, SPANNERS1Cleared 510(K)
- K880413PATELLAR TENDON GRAFT GUIDE1Cleared 510(K)
- K860131ACROMED SPINAL SURGERY INSTRUMENTS1Cleared 510(K)
- K844595ORTHOPEDIC CUSTOM SURGICAL KIT1Cleared 510(K)
- K843942HENNING MENISCAL SUTURE KIT1Cleared 510(K)
- K841970CAMELBACK HANDLE-K841969-LABELING1Cleared 510(K)
- K8419696.5MM HEX HANDLE1Cleared 510(K)
- K834108NEEDLE BENDER TX82251Cleared 510(K)
- K834369CRANE MENISCAL SUTURE SET1Cleared 510(K)
- K834370MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER1Cleared 510(K)
- K833943MENISCAL SUTURING SYSTEM1Cleared 510(K)
- K813000DISPOSABLE ARTHROSCOPY CANNULA SET1Cleared 510(K)
- K803127HOWMEDICA KNEE BRUSH1Cleared 510(K)
- K810267FEMORAL CANAL BRUSH1Cleared 510(K)
- K802694JACOB CHUCK1Cleared 510(K)
- K792670SMITH SUBTALAR PEG1Cleared 510(K)
- 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
- QLQManual Instruments Designed For Use With Total Disc Replacement Devices2Product Code
- QLRManual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices2Product 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
SOFAMOR ORTHOPAEDIC INSTRUMENTS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K933242
- 510(k) Type
- Traditional
- Applicant
- DANEK MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/28/1994
- Days to Decision
- 210 days
- Submission Type
- Statement