meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
44
Latest Decision
1986-09-12

Clearances · page 164 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K863396 CONCEPT INTRAVISION ARTHROSCOPE SYSTEM Concept, Inc. HRX Class II 1986-09-12
K862778 HALL CANNLULA SYSTEM Hall Surgical, Division of Zimmer, Inc. HRX Class II 1986-09-08
K861983 SUTTER LESSER METATARSAL CAP Sutter Biomedical, Inc. KWD Class II 1986-09-08
K863146 BOWEN SUTURE PASSER Bowen & Company, Inc. HXI Class I 1986-09-05
K863147 GLENOID DRILL Bowen & Company, Inc. HTW Class I 1986-09-05
K863149 BOWEN PROBE Bowen & Company, Inc. HXB Class I 1986-09-05
K863148 BOWEN KNOT PASSER Bowen & Company, Inc. HXI Class I 1986-09-05
K863119 CANNULATED LAG SCREWS Downs Surgical , Ltd. HTY Class II 1986-09-03
K862659 CONCEPT ARTHROSCOPY RASP Concept, Inc. HTP Class I 1986-09-02
K862552 ACROMED ADS BONE NAIL Buckman Co., Inc. KTW Class II 1986-09-02
K862689 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP W. L. Gore & Associates, Inc. HXX Class I 1986-09-02
K862535 OSTEONICS SHOULDER PROSTHESIS Osteonics Corp. KWS Class II 1986-09-02
K862230 WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW Buckman Co., Inc. HWC Class II 1986-08-29
K862933 ABC-1000 SMALL JOINT REAMERS Instrumentation Industries, Inc. HTO Class I 1986-08-18
K862275 ARTHROSCOPE Comeg USA, Inc. HRX Class II 1986-08-11
K862504 ACE MOS SAW AND THE ACE MOS SPINE SAW Buckman Co., Inc. JDX Class II 1986-08-07
K862874 THE TOWERED 90/90 UNIT Lossing Orthopedic, Inc. HST Class I 1986-08-07
K862702 TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS Depuy, Inc. LPH Class II 1986-07-30
K862279 EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM Orthospec, Inc. KTW Class II 1986-07-25
K862311 SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN Warsaw Orthopedic, Inc. KTT Class II 1986-07-25
K861266 HOWMEDICA KINEMATIC PLUS KNEE SYSTEM Howmedica Corp. JWH Class II 1986-07-24
K862658 CONCEPT ARTHROSCOPIC KNIFE Concept, Inc. HRX Class II 1986-07-23
K862657 CONCEPT CURETTE Concept, Inc. HRX Class II 1986-07-23
K862509 CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 Lifestream Int'L, Inc. JDY Class I 1986-07-23
K862326 POROUS COATED HIP FEMORAL PROSTHESIS Johnson & Johnson Professionals, Inc. LPH Class II 1986-07-16
K862529 HALL STERILE BUR Hall Surgical, Division of Zimmer, Inc. HTT Class I 1986-07-15
K861715 WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS Dow Corning Wright HSX Class II 1986-07-14
K862136 MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE Dow Corning Wright HSX Class II 1986-07-14
K862225 INTERNATIONAL TOTAL HIP SYSTEM Richards Medical Co., Inc. JDI Class II 1986-07-11
K862057 KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD Kirschner Medical Corp. KWY Class II 1986-07-11
K862128 DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER) Health Products, Inc. KQX Class I 1986-07-11
K860356 ORTHOBLEND POWERED BONE MILL Zimmer, Inc. LYS Class I 1986-07-08
K861766 HOWMEDICA HOFFMANN FIXATION PIN SYSTEM Howmedica Corp. JDW Class II 1986-07-08
K862254 WARSAW ORTHOPEDIC BONE PLATE Warsaw Orthopedic, Inc. HRS Class II 1986-07-08
K861680 OSTEONICS ELBOW PROSTHESIS Osteonics Corp. JDC Class II 1986-06-27
K862125 ARIZONA CONDYLAR TIBIAL PLATEAU Depuy, Inc. HRY Class II 1986-06-27
K861400 THREADED TITANIUM METAL BACKED ACETABULAR CUP Depuy, Inc. LZO Class II 1986-06-17
K855017 LSF* TOTAL HIP SYSTEM Implant Technology, Inc. JDI Class II 1986-06-11
K861930 CM-6 TOTAL HIP SYSTEM Kirschner Medical Corp. JDI Class II 1986-06-11
K861723 (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT Osteonics Corp. KWA Class III 1986-06-09
K861859 CABOT VIDEOSCOPE Cabot Medical Corp. HRX Class II 1986-05-30
K861268 ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH Orthopedic Systems, Inc. HRX Class II 1986-05-16
K861566 SLR BIPOLAR HIP ENDOPROSTHESIS Dow Corning Wright KWY Class II 1986-05-12
K861576 SHORTENING OSTEOTOMY GUIDE Osteotomy Guide Co. HTH Class I 1986-05-12
K861365 FASICULATED NAIL Lake Region Mfg., Inc. HSB Class II 1986-05-06
K860442 PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 Howmedica Corp. LPH Class II 1986-05-06
K861396 HANDHELD DYNAMOMETER, MODEL #160 AND #111 Spark Instruments & Academics, Inc. HRW Class I 1986-05-02
K861164 OSTEOMILL BONE GRINDER Biodynamic Technologies, Inc. LYS Class I 1986-05-02
K861114 MALLORY/HEAD - PF ACETABULAR COMPONENT Biomet, Inc. JDI Class II 1986-04-17
K861137 ORTHOMED ORTHOPAEDIC FIXATION STAPLES Biomedical Exports, Inc. JDR Class II 1986-04-17
K861264 JOINT MEASUREMENT INDICATOR Devcom, Inc. JDL Class III 1986-04-15
K861178 DEPUY COMPRESSION HIP SCREW SYSTEM Depuy, Inc. KTT Class II 1986-04-15
K861086 ZIMMER VACUUM MIXING SYSTEM Zimmer, Inc. JDZ Class I 1986-04-14
K861105 HOWMEDICA BIPOLAR PROSTHESIS Howmedica Corp. KWY Class II 1986-04-14
K860275 TI-FIT ACETABULAR COMPONENT Richards Medical Co., Inc. LZO Class II 1986-04-03
K860002 CONICAL COLLAR HIP PROSTHESIS POROUS COATED Kirschner Medical Corp. JDI Class II 1986-04-01
K855200 MODULAR PRESS FIT (MPF) STEM Depuy, Inc. JDI Class II 1986-04-01
K861073 AMERICAN ORTHOPAEDIC VACUUM 0295-250 Martin Medical LGF Class I 1986-03-28
K861074 AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200 Martin Medical LGF Class I 1986-03-28
K860756 GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD Howmedica Corp. HSB Class II 1986-03-28
K861075 AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202 Martin Medical LGF Class I 1986-03-28
K860226 FORCE EVALUATION AND TESTING SYSTEM (FETS) Hoggan Health Industries, Inc. LBB Class II 1986-03-27
K855183 COFIELD SHOULDER SYSTEM Richards Medical Co., Inc. KWS Class II 1986-03-26
K860016 AESCULAP BONE MILL Aesculap Instruments Corp. LYS Class I 1986-03-19
K860592 ACE IM ROD Buckman Co., Inc. HSB Class II 1986-03-19
K860131 ACROMED SPINAL SURGERY INSTRUMENTS Buckman Co., Inc. LXH Class I 1986-03-19
K860701 HPS II SMOOTH STEM Depuy, Inc. JDI Class II 1986-03-19
K860594 SYNATOMIC REVISION FEMORAL PROSTHESIS Depuy, Inc. JWH Class II 1986-03-14
K860654 M.C.R. KNEE PROSTHESIS (SERIES 3000) Osteonics Corp. JWH Class II 1986-03-14
K860635 OPTI-FIX TOTAL HIP SYSTEM Richards Medical Co., Inc. LPH Class II 1986-03-14
K855042 KM-3 ACETABULAR COMPONENT Kirschner Medical Corp. JDL Class III 1986-03-14
K855166 THACKRAY TOTAL CONDYLAR KNEES Thackray USA JWH Class II 1986-03-13
K860600 SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION 3M Company HRS Class II 1986-03-13
K854107 DIMENSION TOTAL HIP PROSTHESIS POROUS COATED Kirschner Medical Corp. JDL Class III 1986-03-10
K860591 ACE MULTIPLE PIN PLATE Buckman Co., Inc. HRS Class II 1986-03-10
K860133 MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU Depuy, Inc. HRY Class II 1986-03-10
K860590 ACE UNILATERAL FIXATOR Buckman Co., Inc. HTY Class II 1986-03-07
K860607 MARKOPTIC IMPROVED ARTHROSCOPE Markoptic HRX Class II 1986-03-05
K854935 LINK METAL-BACKED ACETABULAR CUPS Link America, Inc. JDL Class III 1986-03-05
K854336 MONOFIXATEUR Ortopedia GmbH HWC Class II 1986-03-05
K854241 AOT EXTERNAL COMPRESS DEVICE Advanced Ortho-Technology, Inc. HWN Class I 1986-03-03
K855231 HOWMEDICA BIPOLAR PROSTHESIS Howmedica Corp. KWY Class II 1986-02-27
K854791 BIO-FIT HIP SYSTEM Richards Medical Co., Inc. KWL Class II 1986-02-27
K854889 FLEX-I-GRASP Euro-Med Intl. HRX Class II 1986-02-21
K853991 HOFMANN KNEE Intermedics Orthopedics JWH Class II 1986-02-21
K860323 REESE ARTHRODESIS SCREW Osteotomy Guide Co. HWC Class II 1986-02-19
K854883 OMKNEE SYSTEM Orthomet, Inc. JWH Class II 1986-02-18
K853730 FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP Protek, Inc. MBV Class II 1986-02-18
K853250 FEMOROTIBIAL MEDULLARY NAIL Zimmer, Inc. HSB Class II 1986-02-12
K854770 MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM Advanced Biosearch Assn. KWP Class II 1986-02-11
K855228 FEMORAL HEMI-HIP PROSTHESES Orthopaedic Device Corp. KWL Class II 1986-02-11
K854465 LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM Link America, Inc. JDI Class II 1986-02-10
K860018 FISCHER WIRE/PIN CLAMP Buckman Co., Inc. HXK Class I 1986-02-07
K860017 ACROMED CANCELLOUS BONE SCREW Buckman Co., Inc. HWC Class II 1986-02-07
K854227 FASCILULATED NAIL The Deca Co. HSB Class II 1986-02-04
K854077 MIX EVAC II Stryker Corp. JDZ Class I 1986-01-31
K854825 LINK SMALL BONE PLATES Link America, Inc. HRS Class II 1986-01-21
K860037 SUSPENDER ORTHOPEDIC SUSPENSION DEVICE Comfortex, Inc. HST Class I 1986-01-21
K853704 LINK DYNAMIC STAPLE Link America, Inc. JDR Class II 1986-01-21
K855179 TRANSFER-TRAX (TM) SPLINT TRACTION Comfortex, Inc. HST Class I 1986-01-21

17,115 clearances in the Orthopedic panel. Data: openFDA.