FDA 510(k) Premarket Notification K040389: COONRAD/MORREY ELBOW CEMENT RESTRICTOR

Submission Details & Decision

Normalized public record details for 510(k) notification K040389.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K040389

Applicant / Sponsor

Zimmer, Inc.

Device Name

COONRAD/MORREY ELBOW CEMENT RESTRICTOR

Product Code

JDC

Decision Date

2004-05-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

2004-02-17

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1061124 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
DePuy Mitek, Inc. Registration: 1221934 View Registration
MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
ZIMMER SURGICAL, INC. Registration: 1526350 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
APS MATERIALS, INC. Registration: 1529009 View Registration
ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
CENTEX MACHINING, INC. Registration: 1645151 View Registration
TORNIER, INC. Registration: 1649390 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
ZIMMER, INC. Registration: 1822565 View Registration
BIOMET, INC. Registration: 1825034 View Registration
ORCHID UNIQUE Registration: 1828288 View Registration
SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
MICROPULSE INC Registration: 1834379 View Registration
NGInstruments, Inc dba Avalign Cutting Instruments Registration: 1835251 View Registration
KEN-MAR MACHINE MFG CORP Registration: 2242737 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
SCT, INC. Registration: 2249615 View Registration
HOWMEDICA OSTEONICS CORP Registration: 2249697 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
Tornier S.A.S. Registration: 3000931034 View Registration
STERIS SPA Registration: 3002806470 View Registration
STERIS SPA Registration: 3002806603 View Registration
IONISOS Registration: 3002807295 View Registration
Phillips Precision Inc Registration: 3003387384 View Registration
OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration
DONSON MACHINE COMPANY Registration: 3004153896 View Registration
Waldemar Link GmbH & Co. KG Registration: 3004371426 View Registration
Viant Medical, LLC Registration: 3004976965 View Registration
TORNIER Inc. Registration: 3004983210 View Registration
SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
APS MATERIALS INC. IRELAND Registration: 3007740680 View Registration
Structure Medical, LLC. Registration: 3007993775 View Registration
Limacorporate S.p.A. Registration: 3008021110 View Registration
Stryker Macroom Registration: 3008337808 View Registration
Limacorporate S.p.A. Registration: 3008395353 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Complexus Medical Registration: 3009887475 View Registration
Isomedix Operations Inc Registration: 3009888344 View Registration
Orchid Orthopedic Solutions Alabama LLC Registration: 3009888740 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
PRECISION FORMS, INC. Registration: 3010041993 View Registration
LH MEDICAL CORPORATION Registration: 3010057495 View Registration
IONISOS Registration: 3010178296 View Registration
INCIPIO DEVICES Registration: 3011015572 View Registration
WESTLAKE PLASTICS EUROPE Registration: 3011274144 View Registration
DOT AMERICA, INC. Registration: 3011461101 View Registration
Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration
ZIMMER PTE. LTD. Registration: 3013176080 View Registration
OEB S.R.L. Registration: 3013791180 View Registration
BIOMET CHILE S.A. Registration: 3014302784 View Registration
Zimmer Biomet Centroamerica SA Registration: 3014315560 View Registration
Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
Arrow International, LLC (subsidiary of Teleflex Incorporated) Registration: 3015859709 View Registration
EDDI BRESSAN S.R.L. Registration: 3017397663 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
STI LUALDI S.R.L. Registration: 3026771806 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
TECRES SPA Registration: 9614841 View Registration
Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 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.