Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 40
- Latest Decision
- 1987-11-02
Clearances · page 162 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K873652 | HOOK PROBE #TM-1376 | Arthropedics, Inc. | HXB | Class I | 1987-11-02 |
| K873711 | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | Arthropedics, Inc. | HTS | Class I | 1987-11-02 |
| K873713 | TRIANGULAR KNIFE, DISPOSABLE #TM-1611 | Arthropedics, Inc. | HTS | Class I | 1987-11-02 |
| K873650 | C-O-T SET (CANNULA, OBTURATOR AND TROCAR) #TM-1360 | Arthropedics, Inc. | HRX | Class II | 1987-11-02 |
| K873797 | TI-FIT TOTAL HIP SYSTEM | Richards Medical Co., Inc. | LWJ | Class II | 1987-11-02 |
| K873651 | BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 | Arthropedics, Inc. | HXB | Class I | 1987-11-02 |
| K873501 | SCISSOR, LEFT | Arthropedics, Inc. | HRR | Class I | 1987-11-02 |
| K872533 | THE CART | Arthropedics, Inc. | HRX | Class II | 1987-11-02 |
| K873502 | SCISSOR, RIGHT | Arthropedics, Inc. | HRR | Class I | 1987-11-02 |
| K873710 | MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 | Arthropedics, Inc. | HWB | Class I | 1987-11-02 |
| K873714 | BANANA KNIFE, DISPOSABLE #TM-1612 | Arthropedics, Inc. | HTS | Class I | 1987-11-02 |
| K870922 | C.L.E. ACETABULAR CUP | Protek, Inc. | JDI | Class II | 1987-10-28 |
| K873429 | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE | Protek, Inc. | MBV | Class II | 1987-10-28 |
| K873715 | BONE PIN CUTTER 18 | Military Engineering, Inc. | HXZ | Class I | 1987-10-28 |
| K873585 | POROUS COATED ACETABULAR CUP | Johnson & Johnson Professionals, Inc. | JDI | Class II | 1987-10-28 |
| K873815 | IOI BIPOLAR PROSTHESIS | Intermedics Orthopedics | KWY | Class II | 1987-10-28 |
| K872986 | MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT | KARL STORZ Endoscopy-America, Inc. | HRX | Class II | 1987-10-28 |
| K872379 | INSALL/BURSTEIN* II MODULAR TOTAL KNEE | Zimmer, Inc. | JWH | Class II | 1987-10-28 |
| K873999 | PREMIER-TOTAL (TM) HIP | Intermedics Orthopedics | JDI | Class II | 1987-10-28 |
| K873459 | ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT | Howmedica Corp. | KTT | Class II | 1987-10-28 |
| K873197 | AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT | Depuy, Inc. | JWH | Class II | 1987-10-23 |
| K873599 | EDI 320 | Cybex | KQX | Class I | 1987-10-16 |
| K873104 | NEER-III GLENOID RESURFACING PROSTHESIS | Kirschner Medical Corp. | KWT | Class II | 1987-10-15 |
| K873620 | NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE. | Kirschner Medical Corp. | KWT | Class II | 1987-10-15 |
| K872949 | ACROMED BONE PLATE BENDER | Buckman Co., Inc. | HXW | Class I | 1987-10-15 |
| K873621 | NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS | Kirschner Medical Corp. | KWT | Class II | 1987-10-15 |
| K873712 | STANDARD KNIFE, DISPOSABLE #TM-1610 | Arthropedics, Inc. | HTS | Class I | 1987-10-15 |
| K872858 | WILLIAMS VERTEBRAL SPREADER | Ace Medical Co. | HXP | Class I | 1987-10-15 |
| K872134 | PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON | Orthomet, Inc. | JWH | Class II | 1987-10-14 |
| K870200 | SUTTER FINGER JOINT PROSTHESIS | Sutter Biomedical, Inc. | KYJ | Class II | 1987-10-09 |
| K873722 | PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 | Martin Medical | LGF | Class I | 1987-10-02 |
| K873720 | CAST CUTTER, 230V MODEL NO. 4183-107 | Martin Medical | LGH | Class I | 1987-10-02 |
| K873718 | CHILD WALKING HEEL PRODUCT NO. 4183-132 | Martin Medical | LGF | Class I | 1987-10-02 |
| K873717 | CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 | Martin Medical | LGF | Class I | 1987-10-02 |
| K873719 | CAST CUTTER, 115V MODEL NO. 4183-106 | Martin Medical | LGH | Class I | 1987-10-02 |
| K872985 | SAMUELSON ACETABULAR CUP | Protek, Inc. | KWA | Class III | 1987-10-01 |
| K873073 | KIRSCHNER NEER-III PROXIMAL HUMERUS | Kirschner Medical Corp. | HSD | Class II | 1987-10-01 |
| K872732 | MCCUTCHEN ACETABULAR CUP PROSTHESIS | Dow Corning Wright | JDI | Class II | 1987-10-01 |
| K871181 | ARTHROCOMBI 5003 | F.M. Wiest USA, Inc. | HRX | Class II | 1987-09-29 |
| K871180 | ARTHRO AUTOMAT 5002 | F.M. Wiest USA, Inc. | HRX | Class II | 1987-09-29 |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Holter-Hausner Intl. | HXA | Class II | 1987-09-28 |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Holter-Hausner Intl. | HXA | Class II | 1987-09-28 |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Holter-Hausner Intl. | HXA | Class II | 1987-09-28 |
| K873514 | JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS | Johnson & Johnson Professionals, Inc. | KWY | Class II | 1987-09-24 |
| K873458 | HOWMEDICA PCA COLLARED FEMORAL STEM | Howmedica Corp. | JDG | Class II | 1987-09-23 |
| K873251 | OMNIFIT BONE SCREW | Osteonics Corp. | HWC | Class II | 1987-09-18 |
| K873507 | LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM | Link America, Inc. | JDR | Class II | 1987-09-16 |
| K873089 | PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM | Howmedica Corp. | JDG | Class II | 1987-09-16 |
| K873030 | CONCEPT ARTHROSCOPIC PORTAL ROD | Concept, Inc. | HRX | Class II | 1987-09-16 |
| K870924 | CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT. | Protek, Inc. | KWA | Class III | 1987-09-14 |
| K870923 | SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX. | Protek, Inc. | KWA | Class III | 1987-09-14 |
| K864999 | KENNEDY STEM | Allo Pro Corp. | JDI | Class II | 1987-09-09 |
| K873191 | ACROMED INTERBODY DEPTH GAUGES | Buckman Co., Inc. | HTJ | Class I | 1987-09-09 |
| K872544 | IRRIGATION PRESSURE MONITOR | Avec Scientific Design Corp. | HRX | Class II | 1987-09-04 |
| K873067 | ACROMED BONE SCREW TAP SLEEVES | Buckman Co., Inc. | HWX | Class I | 1987-09-02 |
| K873066 | ACROMED SCREW DRIVER | Buckman Co., Inc. | HXX | Class I | 1987-09-02 |
| K871349 | HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT | Howmedica Corp. | JWH | Class II | 1987-09-01 |
| K873005 | TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS | Techmedica, Inc. | HRS | Class II | 1987-09-01 |
| K872454 | BIOMET MODULAR SHOULDER PROSTHESIS | Biomet, Inc. | KWT | Class II | 1987-08-27 |
| K872535 | BIOPRO FEMORAL HIP COMPONENT | Biopro, Inc. | KWL | Class II | 1987-08-26 |
| K872776 | PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT | Depuy, Inc. | KWL | Class II | 1987-08-24 |
| K872989 | MICRINS NEEDLE HOLDER | Micrins Surgical, Inc. | HXK | Class I | 1987-08-21 |
| K872025 | POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS | Depuy, Inc. | KWL | Class II | 1987-08-18 |
| K872859 | ACE CANCELLOUS BONE SCREW | Ace Medical Co. | HWC | Class II | 1987-08-17 |
| K872856 | BIOPRO 32MM BALL | Biopro, Inc. | JDI | Class II | 1987-08-17 |
| K872224 | MODIFIED TROCHANTER CABLE GRIP SYSTEM | Howmedica Corp. | KTT | Class II | 1987-08-17 |
| K871539 | ZINDRICK IM ROD | Buckman Co., Inc. | HSB | Class II | 1987-08-17 |
| K872266 | CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE | Dow Corning Wright | JWH | Class II | 1987-08-14 |
| K872121 | K AND D HOME TRACT | Joseph A. Kott, M.D. | HST | Class I | 1987-08-12 |
| K872878 | TRI-LOCK MODIFIED FEMORAL PROSTHESIS | Depuy, Inc. | KWL | Class II | 1987-08-07 |
| K872842 | PIN, HIP, KNOWLES | Military Engineering, Inc. | HTY | Class II | 1987-08-07 |
| K871947 | MODIFIED HUCKSTEP INTRAMEDULLARY NAIL | Downs Surgical , Ltd. | HSB | Class II | 1987-08-05 |
| K872735 | HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS. | Howmedica Corp. | HSX | Class II | 1987-08-04 |
| K871776 | WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY | Dow Corning Wright | JWH | Class II | 1987-08-03 |
| K871146 | GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) | Richards Medical Co., Inc. | JWH | Class II | 1987-07-31 |
| K872738 | CORTICAL BONE SCREWS | Military Engineering, Inc. | HWC | Class II | 1987-07-30 |
| K872502 | M.W.P. WRIST PROSTHESIS | Protek, Inc. | KWM | Class II | 1987-07-23 |
| K871870 | HSC UNIT ROD | Research Development Corp. | KWP | Class II | 1987-07-21 |
| K872156 | CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM | Concept, Inc. | HWC | Class II | 1987-07-21 |
| K872270 | ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP | Orthoconcept, Inc. | HRX | Class II | 1987-07-21 |
| K872019 | BI-ARTICULAR II HIP DEVICE | Zimmer, Inc. | KWY | Class II | 1987-07-21 |
| K871585 | MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM | Depuy, Inc. | JWH | Class II | 1987-07-21 |
| K871402 | MURRAY/WELCH TOTAL HIP SYSTEM | Kirschner Medical Corp. | JDI | Class II | 1987-07-16 |
| K872389 | PRECISION SCREW DRIVER SET | Med-Tool, Inc. | HXX | Class I | 1987-07-15 |
| K871453 | ZWEYMUELLER-SL HIP PROSTHESIS STEM | Allo Pro Corp. | KWA | Class III | 1987-07-13 |
| K872538 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS | Vitaphore Corp. | JEC | Class II | 1987-07-10 |
| K864912 | PDS (POLYDIOXANON) ABSORBABLE PIN | Johnson & Johnson Professionals, Inc. | HTY | Class II | 1987-07-09 |
| K870273 | LACEY METAL BACKED PATELLA PROSTHESIS | Dow Corning Wright | JWH | Class II | 1987-07-01 |
| K871347 | WAGNER REVISIONAL FEMORAL HIP PROSTHESIS | Protek, Inc. | JDI | Class II | 1987-07-01 |
| K870085 | ANTERIOR SPINAL FIXATION PLATE | Terray Manufacturing, Inc. | KWP | Class II | 1987-06-30 |
| K871814 | SARMIENTO FOREARM NAIL | Depuy, Inc. | HSB | Class II | 1987-06-30 |
| K872223 | MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM | Howmedica Corp. | KTT | Class II | 1987-06-26 |
| K872084 | POROCOAT MARK II TOTAL ELBOW | Depuy, Inc. | JDC | Class II | 1987-06-25 |
| K871956 | MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT | Downs Surgical , Ltd. | KWA | Class III | 1987-06-23 |
| K871872 | HI MARC INTERLOCKING NAIL | Depuy, Inc. | HSB | Class II | 1987-06-23 |
| K871857 | HPS II CALCAR FEMORAL PROSTHESIS | Depuy, Inc. | JDI | Class II | 1987-06-23 |
| K871900 | OVER DRAPE LEG HOLDER | Avec Scientific Design Corp. | KQZ | Class I | 1987-06-16 |
| K871656 | ORTHOMET AUSTIN-MOORE SYSTEM | Orthomet, Inc. | KWL | Class II | 1987-06-09 |
| K871621 | THE KARL STORZ MODEL 28805 ARTHRO PUMP | KARL STORZ Endoscopy-America, Inc. | HRX | Class II | 1987-06-05 |
| K871462 | PROSTHETIC - FEMORAL HIP COMPONENT | Louis A. Serafin, Jr., M.D. | JDI | Class II | 1987-06-04 |
17,115 clearances in the Orthopedic panel. Data: openFDA.