Arthrex Korea Ltd.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3013700547	3013700547	Arthrex Korea Ltd.	1	N	2027-01-01	Parnas Tower, 20th Floor 521 Teheran-ro Gangnam-gu Seoul KR 06164

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
296263	1196806715	K971723	FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)	MBI	1997-07-30
296263	1201265194	K961228	KARL STORZ MAGNIFYING ARTHROSOCPES	HRX	1996-10-10
296263	1943372863	K941541	HSV LAPAROSCOPY SET	GCJ	1994-05-16
296263	1635148370	K932699	ARTHREX AR-8200 SHAVER SYSTEM	HWE	1994-01-25
296263	1534704471	K241361	Arthrex Synergy Vision Endoscopic Imaging System	GCJ	2024-07-25
296263	1121776559	K232973	Arthrex Knee FiberTak® Button Suture Anchor	MBI	2023-11-15
296263	1570822525	K231113	Arthrex FiberTak Suture Anchor	MBI	2023-05-18
296263	1443177867	K223759	Arthrex SynergyID Endoscopic Imaging System	GCJ	2023-02-24
296263	1650670333	K222263	Arthrex Self Punching SwiveLock Suture Anchors	MAI	2022-08-26
296263	2052033385	K210994	Arthrex Beveled FT Screws	HWC	2021-06-01
296263	1729344289	K203495	Arthrex SwiveLock Anchor	MAI	2021-04-19
296263	2059887981	K203294	Arthrex Pilon Fusion System	HRS	2021-02-03
296263	1641866470	K203268	Arthrex FiberTak Suture Anchor	MBI	2020-11-27
296263	1012772476	K203239	Arthrex Low Profile Screws	HWC	2020-12-30
296263	1816684943	K202582	Arthrex SynergyID Endoscopic Imaging System	GCJ	2021-07-22
296263	1064571647	K201134	Arthrex NanoScope System	GCJ	2020-09-04
296263	1127854339	K201132	Arthrex Compression Screws	HRS	2020-07-27
296263	1677870257	K200341	Arthrex FiberTak Suture Anchor	MBI	2020-03-12
296263	1220515949	K191226	Arthrex SwiveLock Suture Anchor	MAI	2019-06-11
296263	1202533516	K181769	Arthrex FiberTak Suture Anchor	MBI	2018-09-21
296263	1329878334	K180594	Knotless SutureTak Anchors	MAI	2018-06-22
296263	1678633281	K173788	Arthrex Corkscrew FT	MAI	2018-03-01
296263	1488723877	K172612	FiberTak DX	MBI	2017-09-28
296263	1664019313	K161581	Arthrex Synergy RF System	GEI	2016-09-09
296263	1502380968	K153218	Arthrex Synergy UHD4 System	GCJ	2016-02-12
296263	1527350284	K151732	Arthrex Fracture Plates	HRS	2015-08-28
296263	1089423870	K151230	Arthrex FiberTak Anchors	MBI	2015-06-19
296263	1058487816	K150648	Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm	MBI	2015-08-20
296263	1860300877	K150456	Arthrex Plates, Screws, and Staples	HRS	2015-04-29
296263	1394600963	K143745	Arthrex Corkscrew and SwiveLock Suture Anchors	MBI	2015-07-02
296263	1193547645	K143614	Arthrex Low Profile Screws	HWC	2015-01-16
296263	1628979145	K143139	Arthrex Fracture System	HRS	2015-01-16
296263	1057869136	K141735	ARTHREX ANKLE FUSION PLATING SYSTEM	HRS	2014-08-15
296263	1174836862	K141478	ARTHREX FRACTURE PLATES AND SCREWS	HRS	2014-07-08
296263	1918508286	K140855	ARTHREX SUTURETAK SUTURE ANCHORS	MAI	2014-12-18
296263	2046443797	K133275	MINI TIGHTROPE	HTN	2014-01-30
296263	1176882465	K131474	ARTHREX DISTAL RADIUS PLATE SYSTEM	HRS	2013-07-03
296263	1940918789	K123341	ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON	MBI	2012-12-21
296263	1701196858	K123241	ARTHREX FRACTURE PLATES	HRS	2013-04-05
296263	1547827721	K122374	ARTHREX SUTURE (UHMWPE)	GAT	2012-09-25
296263	1322981987	K112990	ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE	HTY	2011-12-19
296263	1700442493	K112437	ARTHREX FRACTURE SYSTEM	HTN	2011-12-21
296263	1245165659	K111253	ARTHREX DISTAL EXTREMITY PLATE SYSTEM	HRS	2011-08-02
296263	1381765463	K110660	ARTHREX BIOCOMPOSITE SUTURETAK	MAI	2011-03-31
296263	1198919747	K110123	PCL TIGHTROPE	HTY	2011-04-28
296263	1234502965	K103705	LOW PROFILE SCREWS	HWC	2011-03-18
296263	1991797874	K103060	ARTHREX TIBIAL GRAFTBOLT	MBI	2011-01-05
296263	1404419440	K101823	ARTHREX SWIVELOCK ANCHORS	MAI	2011-01-07
296263	1056593767	K101679	ARTHREX PUSHLOCK ANCHORS	MAI	2010-10-22
296263	1794093700	K093912	ARTHREX TIBIAL GRAFTBOLT	MBI	2010-03-18
296263	1765081082	K092381	IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION	HRS	2009-10-27
296263	1635503371	K091844	ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS	MAI	2009-08-28
296263	1694342628	K083707	ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE	HRX	2009-08-03
296263	1558252275	K082810	ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW	MAI	2009-01-23
296263	1015150221	K080560	HENKE SASS WOLF OF AMERICA ARTHROSCOPE	HRX	2008-03-18
296263	2023594562	K080111	ARTHREX COMPRESSION STAPLE	JDR	2008-02-13
296263	1118173825	K071756	ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE	GCJ	2007-08-15
296263	1454007827	K071176	MODIFICATION TO: ARTHREX INTERFERENCE SCREW	MAI	2007-08-03
296263	1103054165	K071032	ARTHREX UNIVERS II SHOULDER PROSTHESIS	KWS	2007-08-20
296263	1475982281	K063479	ARTHREX PUSHLOCK	HWC	2006-12-13
296263	1089927657	K062747	ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM	HRS	2006-09-29
296263	1978667268	K062466	ARTHREX INTERFERENCE SCREW	MAI	2006-11-29
296263	1158340470	K061863	ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY	HWC	2006-10-19
296263	1732348087	K060478	ARTHREX BIO-COMPRESSION SCREW	HWC	2006-05-19
296263	1776737743	K053543	ARTHREX ARTHOERESIS IMPLANT	HWC	2006-04-03
296263	1818955615	K053338	ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS	HWC	2006-01-26
296263	2019525600	K052776	TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD	HTN	2005-12-13
296263	2018495756	K052614	LOW PROFILE PLATE AND SCREW SYSTEM	HRS	2005-09-28
296263	1063008414	K051726	ARTHREX TENODESIS FAMILY	HWC	2005-09-27
296263	1617331402	K050749	ARTHREX TAK FAMILY	HWC	2005-05-12
296263	1525377541	K050259	ARTHREX BIO-PIN	HTY	2005-05-27
296263	1479252075	K043337	ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR	HWC	2004-12-14
296263	1828708923	K043248	TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS	HTN	2005-02-16
296263	1633499286	K041965	ARTHREX HUMERAL FRACTURE PLATES AND SCREWS	HRS	2004-09-08
296263	2036876328	K041553	ARTHREX SUTURE GRAFTING KIT	GAT	2004-12-10
296263	1382533468	K040907	ARTHREX SMALL FRAGMENT PLATES AND SCREWS	HRS	2004-07-01
296263	1322534300	K032187	ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM	HRS	2003-09-22
296263	1809540857	K024291	ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475	HRX	2003-03-20
296263	1767566092	K023986	ARTHREX OPES ELECTRODES AND ACCESSORIES	GEI	2002-12-17
296263	1537217654	K003227	BIO-ABSORBABLE CORKSCREW MODEL AR-1920B	MAI	2001-01-08
296263	1359836396	BK070069
296263	1161084072
296263	1192375044
296263	1267391307
296263	1271608110
296263	1304734689
296263	1310387745
296263	1353211118
296263	1369543475
296263	1401594004
296263	1409456947
296263	1441412956
296263	1704576765
296263	1715601290
296263	1732451202
296263	1821510143
296263	1877263918
296263	1916205510
296263	1935228528
296263	2006747056
296263	2030039678

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HRS	16	2021-02-03
MAI	14	2022-08-26
MBI	13	2023-11-15
HWC	12	2021-06-01
GCJ	7	2024-07-25
HTN	4	2014-01-30
HRX	4	2009-08-03
HTY	3	2011-12-19
GEI	2	2016-09-09
GAT	2	2012-09-25
JDR	1	2008-02-13
KWS	1	2007-08-20
HWE	1	1994-01-25