FDA 510(k) Premarket Notification K180121: Rafugen DBM

Submission Details & Decision

Normalized public record details for 510(k) notification K180121.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K180121

Applicant / Sponsor

Cellumed Co., Ltd.

Device Name

Rafugen DBM

Product Code

MQV

Decision Date

2018-04-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

2018-01-16

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Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics Registration: 1000307092 View Registration
Himed, LLC Registration: 1000577893 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 1030489 View Registration
BIOMET MICROFIXATION Registration: 1032347 View Registration
EXACTECH, INC. Registration: 1038671 View Registration
WRIGHT MEDICAL TECHNOLOGY, INC. Registration: 1043534 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
Sterigenics U.S. LLC Registration: 1054811 View Registration
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Sterigenics US LLC Registration: 1058584 View Registration
G-5 FLORIDA LLC Registration: 1066368 View Registration
Citra Labs LLC Registration: 1216032 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1219655 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
ARCH Medical Solutions - Seabrook Registration: 1221763 View Registration
Millstone Medical Testing - CT, LLC Registration: 1222747 View Registration
ETEX Corporation Registration: 1225112 View Registration
LYOPHILIZATION SERVICES OF NEW ENGLAND, INC. Registration: 1225991 View Registration
MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
BAXTER HEALTHCARE CORPORATION Registration: 1416980 View Registration
ARGON MEDICAL DEVICES, INC. Registration: 1417485 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
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Sterigenics US, LLC Registration: 1526534 View Registration
MedXL Registration: 1644312 View Registration
QUALITY BIORESOURCES, INC Registration: 1645368 View Registration
IPAX, INC. Registration: 1720734 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
WARSAW ORTHOPEDIC, INC. Registration: 1824199 View Registration
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INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
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BIOSEAL Registration: 2027062 View Registration
OSTEOMED Registration: 2027754 View Registration
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BIOPLATE, INC. Registration: 2029447 View Registration
Synergy Health AST, LLC Registration: 2030598 View Registration
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NUVASIVE, INC. Registration: 2031966 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
ISOTIS ORTHOBIOLOGICS, INC Registration: 2090010 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
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Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics Registration: 2249062 View Registration
COLLAGEN MATRIX, INC. Registration: 2249852 View Registration
OSTEOTECH, INC. Registration: 2249915 View Registration
DSM Biomedical, Inc. Registration: 2530154 View Registration
The E F PRECISION GROUP Registration: 2531195 View Registration
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MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO Registration: 2647346 View Registration
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BIOMATLANTE Registration: 3002673655 View Registration
RTI Surgical, Inc. (dba RTI Biologics, Inc.) Registration: 3002719998 View Registration
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Synergy Health Ireland Ltd Registration: 3002807314 View Registration
SYNERGY HEALTH STERILISATION UK LTD Registration: 3002807315 View Registration
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ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
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CHINA BIOTECH CORP. Registration: 3003455467 View Registration
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CURASAN AG Registration: 3003771570 View Registration
IONISOS Registration: 3003775072 View Registration
HANS BIOMED CORP. Registration: 3003828812 View Registration
STRYKER SPINE Registration: 3004024955 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration
MAXIGEN BIOTECH, INC. Registration: 3004146122 View Registration
APATECH LTD. Registration: 3004450973 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
SCIENCE & BIO MATERIALS, S.B.M. SAS Registration: 3004549189 View Registration
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K2M, INC. Registration: 3004774118 View Registration
LDR MEDICAL Registration: 3004788213 View Registration
CURASAN AG, FRANKFURT FACILITY Registration: 3004847139 View Registration
Xtant Medical Holdings, Inc. Registration: 3005031160 View Registration
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ABYRX, INC. Registration: 3005972619 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
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ARTHREX GMBH Registration: 3007193505 View Registration
Cytophil, Inc Registration: 3007225376 View Registration
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BONALIVE LTD Registration: 3008328709 View Registration
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SYNERGY BIOMEDICAL Registration: 3010258202 View Registration
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