FDA 510(k) Premarket Notification K020905: NBX - NON-BRIDGING EXTERNAL FIXATOR

Submission Details & Decision

Normalized public record details for 510(k) notification K020905.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K020905

Applicant / Sponsor

Biomet Orthopedics, Inc.

Device Name

NBX - NON-BRIDGING EXTERNAL FIXATOR

Product Code

LXT

Decision Date

2002-04-15

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Special

Third Party Flag

Date Received

2002-03-20

Related Establishments / Registrations

Paragon Medical Inc. Registration: 1000517406 View Registration
SMITH & NEPHEW, INC. Registration: 1020279 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
Sterigenics U.S. LLC Registration: 1054811 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
GEOTEC, INC. Registration: 1222773 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
DEPUY SPINE, INC. Registration: 1526439 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
SMITH & NEPHEW INC. Registration: 1643264 View Registration
ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
BIOMET, INC. Registration: 1825034 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
MAITLAND ENGINEERING Registration: 1835572 View Registration
Paragon Medical Inc. Registration: 1835831 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
JMG MACHINE, INC. Registration: 2031910 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
GAUTHIER BIOMEDICAL, INC. Registration: 2134947 View Registration
ORTHOFIX US LLC Registration: 2183449 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
RMS CO. Registration: 2183946 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
A.M. SURGICAL, INC. Registration: 2437731 View Registration
Synthes GMBH Registration: 3000270450 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
QUINTUS, INC. Registration: 3003108161 View Registration
Phillips Precision Inc Registration: 3003387384 View Registration
ALDEN TOOL COMPANY, INC. Registration: 3003525643 View Registration
COMPOSITES BUSCH SA Registration: 3003860203 View Registration
JEIL MEDICAL CORPORATION Registration: 3004049923 View Registration
GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 View Registration
Viant Medical, LLC Registration: 3004976965 View Registration
TORNIER Inc. Registration: 3004983210 View Registration
SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
MICRO PRECISION SWISS Registration: 3005497913 View Registration
PACIFIC INSTRUMENTS INC. Registration: 3005641619 View Registration
NUTEK Orthopaedics, Inc Registration: 3005893246 View Registration
ADVANCED CONCEPT INNOVATIONS LLC Registration: 3006015326 View Registration
CREATEC GmbH & CO. KG Registration: 3006694268 View Registration
SKELETAL DYNAMICS, INC Registration: 3006742481 View Registration
STRUCTURE MEDICAL, LLC. Registration: 3006783837 View Registration
Zhejiang Biomet Medical Products Co., Ltd. Registration: 3006801265 View Registration
BIOMET FRANCE Registration: 3006946279 View Registration
Smith & Nephew, Inc. Registration: 3007366790 View Registration
Paragon Medical Device (Changzhou) Co., Ltd. Registration: 3007539489 View Registration
MICROWARE PRECISION CO., LTD. Registration: 3007738812 View Registration
Changzhou Biomet Medical Devices Co., Ltd. Registration: 3007923096 View Registration
Structure Medical, LLC. Registration: 3007993775 View Registration
SYMMETRY MEDICAL POLYVAC SAS Registration: 3008534770 View Registration
Smith & Nephew, Inc. Registration: 3008744062 View Registration
Synthes (USA) Products LLC Registration: 3008812560 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
SYNTHES GMBH Registration: 3009417901 View Registration
HPF S.R.L. Registration: 3009546990 View Registration
JATEX, INC. Registration: 3010049501 View Registration
BRANCH MEDICAL GROUP Registration: 3010120104 View Registration
MAWATEC AG Registration: 3010158639 View Registration
Synergy Health Marseille SAS Registration: 3010162973 View Registration
HN AND M GMBH Registration: 3010287687 View Registration
SIMAGEC Registration: 3010462278 View Registration
Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration
Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration
ZIMMER PTE. LTD. Registration: 3013176080 View Registration
Ascension Orthopedics, Inc. Registration: 3014207283 View Registration
BIOMET CHILE S.A. Registration: 3014302784 View Registration
Zimmer Biomet Centroamerica SA Registration: 3014315560 View Registration
Suzhou Ahno Medical Devices Co., Ltd. Registration: 3014315669 View Registration
ABLE MEDICAL DEVICES Registration: 3014680795 View Registration
JEIL MEDICAL CORPORATION Registration: 3014937101 View Registration
Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
Jabil Inc. (Brandywine) Registration: 3015212339 View Registration
Jabil Inc. (Monument) Registration: 3015399803 View Registration
Jabil Inc. (Elmira) Registration: 3015440604 View Registration
Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
Jabil Switzerland Manufacturing GmbH (Raron) Registration: 3015869121 View Registration
Jabil Switzerland Manufacturing GmbH (Grenchen) Registration: 3015869492 View Registration
Jabil Switzerland Manufacturing GmbH (Hagendorf) Registration: 3015876273 View Registration
Jabil Switzerland Manufacturing GmbH (Bettlach) Registration: 3015882686 View Registration
BRANCH MEDICAL GROUP Registration: 3019767615 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
ACUMED LLC Registration: 3025141 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
Medline ReNewal Registration: 3032391 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
DePuy Synthes Sales Registration: 3034676720 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
New Paradigm Biomedical, LLC Registration: 3043355196 View Registration
STRYKER GmbH Registration: 8031020 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
MEDICALPLASTIC Registration: 9611863 View Registration
CHARLES PERY & CIE Registration: 9615800 View Registration
ORTHOFIX SRL Registration: 9680825 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.