meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
48
Latest Decision
1978-11-08

Clearances · page 171 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K781839 BONE CLAMP, ACE EXTERNAL Ace Orthopedic Manufacturing Co. JEC Class II 1978-11-08
K781841 BAR, DISTRACTION Ace Orthopedic Manufacturing Co. JEC Class II 1978-11-08
K781754 SPLINT, HOAKE INFLATABLE AIR Depuy, Inc. KQZ Class I 1978-11-08
K781840 EXTERNAL ARTICULATION Ace Orthopedic Manufacturing Co. JEC Class II 1978-11-08
K781668 GAMMA RADIATION STERILIZATION PRECEDURE Cutter Laboratories, Inc. KYJ Class II 1978-11-03
K781793 FRAME, UNIVERSAL DAY B.G. Orthopedic Corp. JEC Class II 1978-11-03
K781735 ENDOPROSTHESIS SYSTEM, VARIO-HEAD Waldemar Link GmbH & Co. KG KWY Class II 1978-10-24
K781647 BACK TRAC Tech Engineering, Inc. HST Class I 1978-10-17
K781451 FLAT WRENCH Orthopedic Equipment Co., Inc. HXS Class I 1978-09-27
K781608 CENTRAL PEG TIBIAL COMPONENT Howmedica Corp. HRY Class II 1978-09-27
K781443 HARRINGTON SPINE INSTRUMENTATION Orthopedic Equipment Co., Inc. KWP Class II 1978-09-27
K781444 OUTRIGGER DISTRACTION UNIT Orthopedic Equipment Co., Inc. KWP Class II 1978-09-27
K781490 TILLMAN HIPSURFACE REPLACEMENT Waldemar Link GmbH & Co. KG KXA Class II 1978-09-20
K781251 THREADED PIN, SELF DRILLING Ace Orthopedic Manufacturing Co. JDW Class II 1978-08-31
K781389 BIOMET CONCENTRIC HEX SCREW Biomet, Inc. JDO Class II 1978-08-21
K781294 PROSTHESIS, KNEE, TOTAL Biomet, Inc. JWH Class II 1978-08-14
K781091 KNEE INSTRUMENTATION, CONDYLAR Biomet, Inc. HWT Class I 1978-07-17
K780904 KNEE, TOTAL, FEMORAL & TIBIAL Depuy, Inc. MBV Class II 1978-06-22
K780773 PROSTHESIS, HIP, CATHCART, SCHILLER MOD. Depuy, Inc. JDG Class II 1978-06-22
K780497 SPHERISTEM TOTAL HIP PROSTHESIS American Ortomed Corp. JDG Class II 1978-06-14
K780857 MIXING BOWL & SPATULA, DISPOSABLE Howmedica Corp. JDZ Class I 1978-06-13
K780763 ENTRAX TRACTION UNIT Orthopedic Equipment Co., Inc. HSR Class I 1978-05-16
K780330 TOTAL HIP, LORD MADREPORIC Howmedica Corp. KWA Class III 1978-05-12
K780299 TOTAL KNEE SYSTEM Richard'S Medical Equip., Inc. HRY Class II 1978-04-27
K780357 TITANIUM MULLER TOTAL HIP Biomet, Inc. JDG Class II 1978-04-05
K780397 ORTHOPEDIC FORCEPS Orthopedic Equipment Co., Inc. HTX Class I 1978-03-22
K780398 CUP, ACETABULAR, LONG POSTERIOR WALL Orthopedic Equipment Co., Inc. JDI Class II 1978-03-21
K780320 PASSIVE TENDON IMPLANT Holter-Hausner Intl. HXA Class II 1978-03-17
K780329 TOTAL HIP, NEW ENGLAND BAPTIST Depuy, Inc. JDG Class II 1978-03-17
K780283 INSERTER, PLUG, BONE, LIDGE Depuy, Inc. LGF Class I 1978-03-17
K780284 TIBIAL PLATEU Depuy, Inc. MBV Class II 1978-03-15
K780187 NAIL, MASSIE II Howmedica Corp. JDO Class II 1978-03-15
K780317 TOTAL HIP SYSTEM, HARRIS HD2 Howmedica Corp. JDI Class II 1978-03-06
K780266 BONE CEMENT APPLICATOR Zimmer, Inc. KIH Class I 1978-02-28
K780300 HIP PLATE REMOVAL INSTRUMENT Richard'S Medical Equip., Inc. HWB Class I 1978-02-28
K780228 TRACTION UNITS Biomet, Inc. HST Class I 1978-02-23
K780233 TRACTION WEIGHT BAGS Biomet, Inc. HST Class I 1978-02-23
K780235 ORTHOPEDIC DEVICES Biomet, Inc. HWC Class II 1978-02-23
K780202 MONOMER EVACUATION SYSTEM Medishield, Inc. JDY Class I 1978-02-21
K780132 IMPLANT, HINGE TOE, FLEX. Dow Corning Corp. Healthcare Industries Materials KWH Class II 1978-02-06
K780052 PROSTHESIS, DOUBLE CUP Depuy, Inc. JDI Class II 1978-01-20
K772388 CONVERSE-GILLIES NEEDLE HOLDER Edward Weck, Inc. HXK Class I 1978-01-20
K772413 PINCH GUAGE Fred Sammons, Inc. HRW Class I 1978-01-05
K772415 DYNAMETER 50 LB. Fred Sammons, Inc. HRW Class I 1978-01-05
K772120 TOTAL HIP, CHARNELY TYPE Depuy, Inc. JDG Class II 1977-12-20
K772225 PATELLAR PROSTHESIS Cutter Laboratories, Inc. JWH Class II 1977-12-08
K771511 TOTAL KNEE PROSTHESIS-NONCONSTRAINED 3M Company HSX Class II 1977-11-30
K772081 NAIL, INTRAMEDULLARY, FLEXIBLE Depuy, Inc. HSB Class II 1977-11-11
K771851 ARTHROSCOPE OPERATIVE KNIFE SET Richard Wolf Medical Instruments Corp. HTS Class I 1977-10-27
K771710 WORRELL PATELLA TEMPLATE Depuy, Inc. HWT Class I 1977-10-06
K771709 WORRELL TRIAL PATELLA Depuy, Inc. HWT Class I 1977-10-06
K771708 WORRELL PATELLA Depuy, Inc. HTG Class II 1977-10-06
K771418 PIN RETRACTORS Stryker Corp. HTY Class II 1977-09-22
K771598 PATELLA PROSTHESIS/TRAIL COMPONENT Depuy, Inc. JWH Class II 1977-08-26
K770898 FRACTURE CAST BRACE KIT, PLASTIC Chase Mfg. Co. HSP Class I 1977-07-21
K771200 ORTHOSCOPE Stryker Corp. HRX Class II 1977-07-21
K770690 MASK, VAPOR, MONOMER Howmedica Corp. JDY Class I 1977-07-21
K771288 JAMAR DYNAMOMETEO BK-7498 Fred Sammons, Inc. HRW Class I 1977-07-21
K771109 ORTHOPEDIC SOFT GOODS Orthopedic Systems, Inc. HSS Class I 1977-06-27
K771072 INSERTEO, META.-PHAL.&THUMB CARPO-META Depuy, Inc. HXO Class I 1977-06-27
K770910 MEDISHIELD CERVICAL COLLAR Fraser Sweatman, Inc. HSS Class I 1977-05-25
K770908 PROSTHESIS, HIP, TRAPEZOIDAL-28 Zimmer, Inc. JDI Class II 1977-05-23
K770710 NEEDLE, SPRAY Richard Wolf Medical Instruments Corp. HRX Class II 1977-04-26
K770066 TIBIAL COMPRESSION FRAM FOR FRACTURES Richard F. Kronner, M.D. JEC Class II 1977-03-30
K770471 KERBOULL-CHARNLEY CUP SPECIAL MODEL Howmedica Corp. JDG Class II 1977-03-24
K770473 LAGRANGE LETOURNEL TOTAL HIP FEMORAL Howmedica Corp. JDG Class II 1977-03-17
K770472 PROSTHESIS, VIDAL TOTAL HIP Howmedica Corp. JDL Class III 1977-03-17
K770388 FRACTURE REDUCTION SYS., MODEL OR 1001 Sisan Assoc. JEC Class II 1977-03-14
K770420 FORCEPS, ANKLE INSERTING, CON-AXIAL Depuy, Inc. HSN Class II 1977-03-14
K770421 COMPONENTS, ANKLE, TRIAL, CON-AXIAL Depuy, Inc. HSN Class II 1977-03-14
K770349 RIGID TEACHING ATTACHMENT Richard Wolf Medical Instruments Corp. HWN Class I 1977-03-07
K770219 WATSON-FARRAR TOTAL HIP REPLACEMENT Orthopedic Equipment Co., Inc. JDG Class II 1977-02-17
K770204 CEMENT EXTRACTOR DRILL Depuy, Inc. HXY Class I 1977-02-08
K770184 BI-CENTRIC ENDOPROSTHESES Howmedica Corp. JDG Class II 1977-02-08
K770205 CEMENT CHISELS Depuy, Inc. HWA Class I 1977-02-08
K770203 HAND REAMERS Depuy, Inc. HTO Class I 1977-02-08
K770128 B.G. COMPRESSION SYSTEM Howmedica Corp. HRS Class II 1977-01-26
K770161 MICROFENESTRATED HIP REPLACEMENT COMPON. Medishield, Inc. JDG Class II 1977-01-26
K770130 B.G. FLEXIBLE NAIL SYSTEM Howmedica Corp. JDS Class II 1977-01-26
K770080 BAKER MOBILE TRACTION Orthopedic Equipment Co., Inc. HST Class I 1977-01-25
K770035 SCREW, WADSWORTH OLECRANON Orthopedic Equipment Co., Inc. HWC Class II 1977-01-14
K761324 RESURFACE PROSTHESES FOR HIP JOINT Holco Instrument Corp. KXA Class II 1977-01-05
K761278 TOTAL TIBIAL KNEE Depuy, Inc. HRY Class II 1977-01-05
K761088 DEPUY MODIFIED SKELETAL TRACTION PIN Depuy, Inc. JEC Class II 1976-12-17
K761036 WILSON SPINAL FRAME Orthopedic Equipment Co., Inc. HSQ Class I 1976-12-16
K761243 12-9170 SERIES II TOTAL HIP Richardo Manufacturing Co. JDG Class II 1976-12-16
K761146 SPARBARO TYPE TOTAL HIP Orthopedic Equipment Co., Inc. JDG Class II 1976-12-16
K761150 GALLENAUGH BONE PLATES Orthopedic Equipment Co., Inc. HRS Class II 1976-12-16
K761020 ANKLE (FREEMAN-SWANSON) Medishield, Inc. HSN Class II 1976-11-23
K761021 ANKLE INSTRUMENTS (FREEMAN-SWANSON) Medishield, Inc. HSN Class II 1976-11-23
K760970 FLORIO CPC BAND Richard'S Medical Equip., Inc. HWN Class I 1976-11-23
K761002 CHARNLEY CONGENITAL HIP FEMUR (85-3060) Codman & Shurtleff, Inc. JDG Class II 1976-11-23
K761003 CHARNLEY CONGENITAL HIP FEMUR (85-3061) Codman & Shurtleff, Inc. JDG Class II 1976-11-23
K760974 CHARNLEY FEMORAL COMPONENT Codman & Shurtleff, Inc. JDG Class II 1976-11-16
K760976 CHARNLEY REVISION SET Codman & Shurtleff, Inc. JDG Class II 1976-11-16
K760521 TAPE MEASURE Mcgaw Laboratories KTZ Class I 1976-11-12
K760906 MONOMER VAPOR CONTAINMENT SYSTEM Howmedica Corp. JDY Class I 1976-11-11
K760869 SPLIT CERVICAL COLLAR/HEAD HALTER Orthopedic Equipment Co., Inc. HSS Class I 1976-11-01
K760842 GEOMEDIC ANAMETRIC TOTAL KNEE Howmedica Corp. HRY Class II 1976-10-20
K760744 TAVERNETTI-TENNANT Cutter Laboratories, Inc. HRY Class II 1976-10-07

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