PACIFIC INSTRUMENTS INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005641619	3005641619	PACIFIC INSTRUMENTS INC.	1	Y	2026-01-01	438 Hobron Lane Suite 204 Honolulu HI US 96815

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
66485	1814282701	K213982	Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires	HTY	2022-02-17
66485	2025758906	K191584	FORTICO Anterior Cervical Fixation System	KWQ	2019-10-22
66485	1898418808	K190360	LineSider™ Spinal System	NKB	2019-06-21
66485	1246963121	K171108	AUTOBAHN Nailing System	HSB	2017-12-29
66485	1821154454	K140055	ENDOSKELETON(R) TL INTERBODY FUSION DEVICE	MAX	2014-07-02
66485	2035660911	K133691	EXTRIMILOCK ANKLE PLATING SYSTEM	HRS	2014-02-24
66485	1530467460	K131851	OSTEOMED NEURO RONGEUR	HAE	2013-12-06
66485	1683025306	K131538	CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM	MNH	2013-08-08
66485	1646010789	K124027	MONSTER SCREW SYSTEM	HWC	2013-04-05
66485	1683736240	K122737	GEMINUS FOSSA SPECIFIC PLATE SYSTEM	HRS	2012-10-03
66485	1335837920	K122662	VERTIFLEX DIRECT DECOMPRESSION SYSTEM	HRX	2012-11-13
66485	1283712156	K122332	TOWERLOX PEDICLE SCREW SYSTEM	MNI	2012-10-16
66485	1273015114	K122310	GEMINUS FOSSA SPECIFIC PLATE SYSTEM	HRS	2013-01-18
66485	1749172626	K120570	CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM	MQP	2012-04-05
66485	2007961193	K120345	HONOUR SPACER SYSTEM	ODP	2012-06-13
66485	1314925583	K120292	CAPLOX II PEDICLE SCREW SYSTEM	MNI	2012-04-13
66485	1868525381	K113361	SECURIS SPINAL FIXATION	NKB	2012-04-03
66485	1082127137	K112672	HEADLESS COMPRESSION SCREW	HWC	2011-12-13
66485	1846611240	K111626	ENDOSKELETON(R) TAS	OVD	2011-09-09
66485	1653410189	K111620	SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS	HRS	2011-08-23
66485	1853273032	K111068	STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5	KYI	2011-12-30
66485	1668933727	K110650	ZYSTON ARC INTERBODY SPACER	MAX	2011-06-30
66485	1430423823	K102323	CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE	OVE	2010-12-16
66485	1417857088	K102248	EXCELLA II SPINAL SYSTEM MODEL EC2-00	NKB	2010-10-07
66485	2053367885	K101997	ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	HSB	2011-07-12
66485	1125222659	K100210	TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T	MAX	2010-08-26
66485	1013088689	K092721	ALIGN RADIAL HEAD SYSTEM	KWI	2010-08-03
66485	1772047086	K092720	WRIST ARTHRODESIS NAIL SYSTEM	HSB	2010-06-29
66485	1793396153	K090984	INERTIA PEDICLE SCREW SYSTEM	MNI	2009-06-30
66485	1124032540	K083863	THEKEN ATOLL OCT SPINAL SYSTEM	MNI	2009-03-27
66485	1881181262	K073708	FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM	KWQ	2008-06-03
66485	1900081665	K070638	THEKEN ATOLL CERVICO-THORACIC SYSTEM	KWP	2007-05-30
66485	1002431601
66485	1012712054
66485	1013088689
66485	1032333919
66485	1032858925
66485	1043476459
66485	1048087106
66485	1058596316
66485	1105380760
66485	1108991838
66485	1111450322
66485	1123115561
66485	1182062243
66485	1194870877
66485	1212356296
66485	1213378400
66485	1230235888
66485	1230422711
66485	1236010453
66485	1236486437
66485	1239676357
66485	1243486510
66485	1263453179
66485	1264104592
66485	1308917689
66485	1330885744
66485	1357458013
66485	1387945277
66485	1388799657
66485	1408062901
66485	1433676170
66485	1435666986
66485	1461968079
66485	1484132664
66485	1499909860
66485	1501192488
66485	1530467460
66485	1555119616
66485	1588861774
66485	1589284544
66485	1604688428
66485	1644514650
66485	1645246893
66485	1648621791
66485	1653410189
66485	1658556182
66485	1675622876
66485	1685436998
66485	1700631097
66485	1700907347
66485	1718614845
66485	1727786408
66485	1740216827
66485	1755184563
66485	1797571564
66485	1797737561
66485	1802609168
66485	1804571426
66485	1814566103
66485	1835483450
66485	1841451245
66485	1844831259
66485	1855996081
66485	1859124620
66485	1865864417
66485	1898418808
66485	1901113732
66485	1914457536
66485	1919400498
66485	1929835563
66485	1934265244
66485	1945392244
66485	1946334532
66485	1958238367
66485	1974687661
66485	1983185042
66485	2002198638
66485	2015571582
66485	2041520631
66485	2045159500
66485	2055357183
66485	2065407556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HRS	4	2014-02-24
MNI	4	2012-10-16
NKB	3	2019-06-21
HSB	3	2017-12-29
MAX	3	2014-07-02
KWQ	2	2019-10-22
HWC	2	2013-04-05
HTY	1	2022-02-17
HAE	1	2013-12-06
MNH	1	2013-08-08
HRX	1	2012-11-13
ODP	1	2012-06-13
MQP	1	2012-04-05
KYI	1	2011-12-30
OVD	1	2011-09-09
OVE	1	2010-12-16
KWI	1	2010-08-03
KWP	1	2007-05-30