FDA 510(k) Premarket Notification K771511: TOTAL KNEE PROSTHESIS-NONCONSTRAINED

Submission Details & Decision

Normalized public record details for 510(k) notification K771511.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K771511

Applicant / Sponsor

3M Company

Device Name

TOTAL KNEE PROSTHESIS-NONCONSTRAINED

Product Code

HSX

Decision Date

1977-11-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

1977-08-08

Related Establishments / Registrations

Paragon Medical - Dayton Registration: 1000200989 View Registration
Paragon Medical Inc. Registration: 1000517406 View Registration
MARSON MEDICAL, INC. Registration: 1000550978 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
SMITH & NEPHEW, INC. Registration: 1020279 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
Sterigenics U.S. LLC Registration: 1054811 View Registration
SOUTHEASTERN TECHNOLOGY dba Autocam Medical Registration: 1057425 View Registration
INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration
SMITH & NEPHEW INC. Registration: 1219602 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1219655 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
Primo Medical Group, INC Registration: 1222928 View Registration
JARVIS SURGICAL INC. Registration: 1223434 View Registration
MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration
Instrumed International Inc dba Avalign German Specialty Instruments Registration: 1421101 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
SMITH & NEPHEW INC. Registration: 1643264 View Registration
ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
CENTEX MACHINING, INC. Registration: 1645151 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
ORTHO DEVELOPMENT CORP. Registration: 1722511 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
ZIMMER, INC. Registration: 1822565 View Registration
BIOMET, INC. Registration: 1825034 View Registration
ORCHID ORTHOPEDICS-CHELSEA Registration: 1827096 View Registration
ORCHID UNIQUE Registration: 1828288 View Registration
SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration
INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
EAGLE MEDICAL PACKAGING STERILIZATION, INC. Registration: 2028632 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
LIFE SCIENCE OUTSOURCING, INC. Registration: 2031093 View Registration
Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration
RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
KEN-MAR MACHINE MFG CORP Registration: 2242737 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
SCT, INC. Registration: 2249615 View Registration
HOWMEDICA OSTEONICS CORP Registration: 2249697 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
PULSE TECHNOLOGIES, INC. Registration: 2532027 View Registration
ORTHOPLASTICS LTD Registration: 3000264985 View Registration
3D MEDICAL MANUFACTURING, INC. (dba Tecomet) Registration: 3001239363 View Registration
Arthrex GmbH Registration: 3002579136 View Registration
IONISOS Registration: 3002807295 View Registration
ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
T & L SHARPENING, INC. Registration: 3003541440 View Registration
OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration
MATERIALISE N.V. Registration: 3003998208 View Registration
GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration
ConforMIS, Inc. Registration: 3004153240 View Registration
ARTHROSURFACE, INC. Registration: 3004154314 View Registration
HURON TOOL & CUTTER GRINDING Registration: 3004358587 View Registration
Waldemar Link GmbH & Co. KG Registration: 3004371426 View Registration
Viant Medical, LLC Registration: 3004976965 View Registration
SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
EPTAM PLASTICS, LTD Registration: 3005144609 View Registration
MEDACTA INTERNATIONAL SA Registration: 3005180920 View Registration
SMITH & NEPHEW, INC. Registration: 3005551626 View Registration
TURNER MEDICAL INC. Registration: 3005706667 View Registration
Materialise USA, LLC. Registration: 3005718816 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
CANWELL MEDICAL CO., LTD. Registration: 3006395932 View Registration
STRUCTURE MEDICAL, LLC. Registration: 3006783837 View Registration
Zhejiang Biomet Medical Products Co., Ltd. Registration: 3006801265 View Registration
MEDISTRI SA Registration: 3006946276 View Registration
MAXX ORTHOPEDICS INC. Registration: 3007311878 View Registration
Smith & Nephew, Inc. Registration: 3007366790 View Registration
Paragon Medical Device (Changzhou) Co., Ltd. Registration: 3007539489 View Registration
Zimmer Orthopedic Mfg Ltd Registration: 3007963827 View Registration
Structure Medical, LLC. Registration: 3007993775 View Registration
Synergy Health Radeberg GMBH Registration: 3008102042 View Registration
MEDACTA INTERNATIONAL SA Registration: 3008110533 View Registration
SIGNATURE ORTHOPAEDICS PTY LIMITED Registration: 3008262872 View Registration
Smith & Nephew, Inc. Registration: 3008744062 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
TURNCO TOOL & INSTRUMENT, INC. Registration: 3009241418 View Registration
Materialise Ukraine, Rep. office Registration: 3009555440 View Registration
Materialise Sdn Bhd Registration: 3009555447 View Registration
BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration
ORCHID ORTHOPEDIC SOLUTIONS OREGON, INC. Registration: 3009848551 View Registration
PERRYMAN COMPANY Registration: 3009882462 View Registration
Complexus Medical Registration: 3009887475 View Registration
Isomedix Operations Inc Registration: 3009888344 View Registration
Orchid Orthopedic Solutions Alabama LLC Registration: 3009888740 View Registration
Engineered Medical Systems, LLC Registration: 3009973336 View Registration
ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration
rms Surgical Registration: 3010009693 View Registration
Lincotek Medical LLC Registration: 3010039400 View Registration
ALMARK TOOL & MANUFACTURING COMPANY, INC. Registration: 3010041693 View Registration
AUTOCAM MEDICAL Registration: 3010047402 View Registration
JATEX, INC. Registration: 3010049501 View Registration
Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
APPLIMED SA -CSSR Registration: 3010163695 View Registration
Synergy Health Westport Ltd Registration: 3010173425 View Registration
IONISOS Registration: 3010178296 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
Synergy Sterilisation South Africa Proprietary Ltd Registration: 3010287685 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
PPD MEDITECH, DIV. OF INDUSTRIES PPD INC. Registration: 3010375065 View Registration
TRIBE MEDICAL GROUP Registration: 3010400367 View Registration
MICROPORT ORTHOPEDICS INC. Registration: 3010536692 View Registration
INCIPIO DEVICES Registration: 3011015572 View Registration
Advanced Machine, Inc. Registration: 3011061242 View Registration
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT Registration: 3011187779 View Registration
WESTLAKE PLASTICS EUROPE Registration: 3011274144 View Registration
Suzhou Elite Precision Machinery Co., Ltd. Registration: 3011295718 View Registration
TURNXON PRECISION CO., LTD Registration: 3011534620 View Registration
Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration
Zimmer Orthopedics Manufacturing Limited-Galway Registration: 3012319330 View Registration
implantcast GmbH Registration: 3012523063 View Registration
Ortho Solutions Sdn Bhd Registration: 3012755988 View Registration
Stryker Anngrove Registration: 3013014058 View Registration
Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration
ZIMMER PTE. LTD. Registration: 3013176080 View Registration
ARMBRUSTER GMBH Registration: 3013194153 View Registration
ARVATO Netherlands B.V. Registration: 3013302242 View Registration
BIOMET CHILE S.A. Registration: 3014302784 View Registration
Signature Orthopaedics Europe Ltd Registration: 3014763043 View Registration
Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
Kyocera Medical Technologies, Inc. Registration: 3015398319 View Registration
Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
I-MEDICAL ASIA COMPANY LIMITED Registration: 3015806723 View Registration
Blue Belt Technologies, Inc. Registration: 3016090213 View Registration
ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration
Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration
MAKO SURGICAL CORP. Registration: 3017410889 View Registration
Watershed Idea Foundry, Inc. Registration: 3017597868 View Registration
SHALBY ADVANCED TECHNOLOGIES, INC. Registration: 3020155054 View Registration
MACH MEDICAL Registration: 3020703621 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
Smith and Nephew Operations Sdn. Bhd Registration: 3022142628 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
OVERTURE ORTHOPAEDICS Registration: 3027737826 View Registration
GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
Zimmer Biomet Pty Ltd Registration: 3035366890 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
Smith & Nephew, Inc. Registration: 3038503932 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
HOWMEDICA INTERNATIONAL S. DE R.L., Registration: 9610726 View Registration
SMITH & NEPHEW ORTHOPAEDICS AG Registration: 9613369 View Registration
Corin Limited Registration: 9614209 View Registration
DEPUY (IRELAND) Registration: 9616671 View Registration
STRYKER IRELAND OSTEONICS Registration: 9616680 View Registration
Gammatom S.r.l. Registration: 9681465 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.