FDA.reportPublic FDA data

ALPCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10580631000222175ALPS SOUTH LLC1N2026-01-012895 42ND AVE. NORTH Saint Petersburg FL US 33714
10622543000206291ALPHA MEDICAL L.L.C.1N2026-01-01303 Church St. Ste 111 Rock Hill SC US 29730
10666953003172841ALPHA OMEGA CO. USA INC.1Y2026-01-013160 Campus Drive Suite 200 Norcross GA US 30071
11257973003017595ALPHA BIOSCIENCES, INC.1N2026-01-013651 CLIPPER MILL RD. BALTIMORE MD US 21211
19320151000118260ALPHAPOINTE1N2026-01-017501 PROSPECT AVE KANSAS CITY MO US 64132
20224092022409ALPHAPROTECH, INC.1Y2026-01-011600 W La Quinta Rd Ste 1 NOGALES AZ US 85621
20226942022694ALPHA-OMEGA SERVICES, INC.1N2026-01-019156 ROSE ST BELLFLOWER CA US 90706
20274672027467ALPHATEC SPINE, INC.1Y2026-01-011950 Camino Vida Roble Carlsbad CA US 92008
25307881000522109ALPHA SCIENTIFIC CORP.1N2026-01-01820 Springdale Drive Exton PA US 19341
96151263001610756ALPHA OMEGA ENGINEERING LTD.1N2026-01-01Hamerkava St. 6 Tsiporit Industrial Zone Nof HaGalil Northern IL 1789062
30032897233003289723ALPHA MEDICAL INSTRUMENTS LLC1N2026-01-0123455 Madero Ste B MISSION VIEJO CA US 92691
30036606143003660614ALPHA-OMEGA SERVICES, INC.1N2026-01-011282 BIG WOODS-STARK RD. Vinton LA US 70668
30063589313006358931ALPHA MODALITIES LLC1N2026-01-011111 S 344TH ST STE 205 Federal Way WA US 98003
30077989043007798904ALPHA TEKNIKO1N2026-01-011400 Rose RD Lake Zurich IL US 60047
30089501273008950127ALPINION MEDICAL SYSTEMS Co., Ltd.1N2026-01-014F, 15, Magokjungang 14-ro Gangseo-gu Seoul KR 07789
30092934903009293490ALPINION USA1Y2026-01-0121222 30th Dr SE Ste C-122 Bothell WA US 98021
30093055133009305513ALPHA MANUFACTURING GROUP INC1Y2026-01-015408 46TH ST Maspeth NY US 11378
30107599023010759902Alphapointe1N2026-01-0187-46 123rd street Jamaica NY US 11418
30109496123010949612ALPHAMICRON, INC1N2026-01-011950 State Route 59 Kent OH US 44240
30145279153014527915ALPHA IMAGING LLC1Y2026-01-014455 Glenbrook Road Willoughby OH US 44094
30155370483015537048ALPHATEC SPINE, INC.1N2026-01-01168 Centennial Parkway Unit 170 Louisville CO US 80027
30166729443016672944ALPHA-BIO TEC1N2026-01-0121 HaReches Blvd., POB 264 Modi'in Modi'in Central IL 7171102
30180245903018024590ALPO MEDIZINTECHNIK GMBH1N2026-01-01ALPO-Str. 6 Auerbach in der Oberpfalz Bavaria DE 91275
30198787143019878714Alphatec Spine, Inc.1Y2026-01-014101 Willow Lake Blvd. Memphis TN US 38118
30232308823023230882ALPEP LLC1N2026-01-011547 W. Struck Ave. Suite G Orange CA US 92867

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
187701463989167K993622NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERYGZL2000-01-24
550041669330895K973639ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.DRF1998-04-20
550041929388973K971504HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETERDRF1998-04-20
342511856496717K964910AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERSJAQ1997-03-10
550041138470813K963248FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)DYG1997-02-03
550041580934113K930069BIPOLAR BALLOON PACING CATHETER BY J-LLOYDLDF1994-01-28
550041377629464K920873WEDGE PRESSURE BALLOON CATHETER BY J-LLOYDDQO1993-01-14
550041607928399K920870ANGIOGRAPHIC BALLOON CATHETER BY J LLOYDDQO1993-01-07
550041126419500K920869FLOW DIRECTED THERMODILUTION BALLOON CATHETERDYG1993-01-13
1121441177339617K890128FACELOCK FILTER MASKFXX1989-02-14
1121441036222732K882028COVERALL SHIELDFXX1988-06-15
1121441299288236K882027COMBO-SHIELDFXX1988-06-15
1121441869888187K882026ADD-A-SHIELDFXX1988-06-15
1121441891344591K875302MEDICAL EYE DISPOSABLE SHIELDHOY1988-03-21
1121441798899357K875172DISPOSABLE SURGICAL FACE MASKFXX1988-01-22
1452202066960189K253615Invictus Bands SystemOWI2026-03-25
2954232066960189K253615Invictus Bands SystemOWI2026-03-25
1452201268104771K252842SafeOp 3: Neural Informatix SystemGWF2026-01-11
2954231268104771K252842SafeOp 3: Neural Informatix SystemGWF2026-01-11
1452201884662717K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)OLO2026-02-19
2954231884662717K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)OLO2026-02-19
3173031884662717K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)OLO2026-02-19
1452201021457875K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ2025-08-28
2954231021457875K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ2025-08-28
1452201335595036K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemOVD2025-09-03
2954231335595036K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemOVD2025-09-03
1452201144623766K251080IdentiTi II Cervical Interbody SystemODP2025-07-03
2954231144623766K251080IdentiTi II Cervical Interbody SystemODP2025-07-03
187701633867854K250601Neuro Omega System; NeuroSmart SystemGZL2025-03-30
1452201703624306K243461Calibrate Interbody Systems2025-03-04
2954231703624306K243461Calibrate Interbody Systems2025-03-04
1452201596212009K242364IdentiTi™ II Interbody SystemMAX2024-10-04
2954231596212009K242364IdentiTi™ II Interbody SystemMAX2024-10-04
1452201657673837K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemMAX2024-09-20
2954231657673837K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemMAX2024-09-20
1452202021134546K241519Invictus® Small Stature Spinal Fixation SystemNKB2024-06-21
2954232021134546K241519Invictus® Small Stature Spinal Fixation SystemNKB2024-06-21
1452201515473944K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec CerMAX2025-02-03
2954231515473944K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec CerMAX2025-02-03
1452201674405586K240951Invictus Robotic Navigation InstrumentsOLO2024-06-06
2954231674405586K240951Invictus Robotic Navigation InstrumentsOLO2024-06-06
1452201708200719K240199IntraOp Alignment SystemOWB2024-05-22
2954231708200719K240199IntraOp Alignment SystemOWB2024-05-22
1452201162926625K234092SafeOp 3: Neural Informatix SysteemGWF2024-04-19
2954231162926625K234092SafeOp 3: Neural Informatix SysteemGWF2024-04-19
1452201652591647K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody SystemKWQ2024-02-22
2954231652591647K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody SystemKWQ2024-02-22
342511261485098K233628AOS Interstitial Templates, Needles, and AccessoriesJAQ2024-07-10
342511822348909K233626AOS Marker Seeds (SMG0242-025)JAQ2024-07-02
1452201860894521K232504Calibrate CCX Interbody SystemMAX2023-10-13
2954231860894521K232504Calibrate CCX Interbody SystemMAX2023-10-13
1452201097824337K232413Fusion Robotic Navigation SystemOLO2023-09-08
2954231097824337K232413Fusion Robotic Navigation SystemOLO2023-09-08
3173031097824337K232413Fusion Robotic Navigation SystemOLO2023-09-08
1452202041361775K232345ATEC Posterior Navigated Disc Prep InstrumentsOLO2023-11-02
2954232041361775K232345ATEC Posterior Navigated Disc Prep InstrumentsOLO2023-11-02
1452201907160548K232275Invictus® Spinal Fixation SystemNKB2023-09-27
2954231907160548K232275Invictus® Spinal Fixation SystemNKB2023-09-27
1452201021311455K232173Ascend VBR System, Ascend NanoTec VBR SystemMQP2023-10-06
2954231021311455K232173Ascend VBR System, Ascend NanoTec VBR SystemMQP2023-10-06
1452201109609323K232097IdentiTi ALIF Interbody SystemsOVD2023-09-25
2954231109609323K232097IdentiTi ALIF Interbody SystemsOVD2023-09-25
1452201647860321K232044Invictus Robotic Navigation InstrumentsOLO2023-10-06
2954231647860321K232044Invictus Robotic Navigation InstrumentsOLO2023-10-06
1452201631327503K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemMAX2023-07-13
2954231631327503K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemMAX2023-07-13
1452201397030438K230721ATEC Lateral Plate SystemKWQ2023-05-09
1452201237491306K223765ATEC Lateral Navigation InstrumentsOLO2023-03-23
2954231237491306K223765ATEC Lateral Navigation InstrumentsOLO2023-03-23
1452201781725591K223611Calibrate LTX Interbody SystemMAX2023-03-29
2954231781725591K223611Calibrate LTX Interbody SystemMAX2023-03-29
1310441204777043K223564X-CUBE 50, X-CUBE 60IYN2023-04-17
1452201502393906K223350Remi Robotic Navigation SystemOLO2023-03-13
2954231502393906K223350Remi Robotic Navigation SystemOLO2023-03-13
3173031502393906K223350Remi Robotic Navigation SystemOLO2023-03-13
1452201758776921K223070Remi Robotic Navigation SystemOLO2022-10-28
2954231758776921K223070Remi Robotic Navigation SystemOLO2022-10-28
3173031758776921K223070Remi Robotic Navigation SystemOLO2022-10-28
1452201034029589K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody SytemODP2022-11-17
2954231034029589K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody SytemODP2022-11-17
1452201387247108K222455Calibrate LTX Interbody SystemMAX2022-11-18
2954231387247108K222455Calibrate LTX Interbody SystemMAX2022-11-18
1452201730566642K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody SystemMAX2022-10-07
2954231730566642K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody SystemMAX2022-10-07
1452201238203023K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemPML2022-12-20
2954231238203023K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemPML2022-12-20
1452201126377593K221821ATEC IOM Accessory InstrumentsPDQ2022-09-23
2954231126377593K221821ATEC IOM Accessory InstrumentsPDQ2022-09-23
1310441430104637K221093X-CUBE 70, X-CUBE 90IYN2022-10-14
1310441288497345K220857X-CUBE 50, X-CUBE 60IYN2022-10-13
1452201696859843K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody SystemMAX2022-06-09
2954231696859843K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody SystemMAX2022-06-09
187701693650685K220553Neuro Omega System, NeuroSmart SystemGZL2022-09-16
1452202031094078K214006Invictus® Spinal Fixation SystemNKB2022-04-04
2954232031094078K214006Invictus® Spinal Fixation SystemNKB2022-04-04
1452201844531527K213849SafeOp 2: Neural Informatix SystemGWF2022-03-09
2954231844531527K213849SafeOp 2: Neural Informatix SystemGWF2022-03-09
1310441236330772K213523X-CUBE i8, X-CUBE i9IYN2022-01-28
1452201717203489K213460Invictus Spinal Fixation SystemNKB2021-12-10
2954231717203489K213460Invictus Spinal Fixation SystemNKB2021-12-10
1452201260756728K213443Insignia™ Anterior Cervical Plate SystemKWQ2021-12-15
2954231260756728K213443Insignia™ Anterior Cervical Plate SystemKWQ2021-12-15
1452201784738252K211987ATEC Alignment AppLLZ2021-10-29
2954231784738252K211987ATEC Alignment AppLLZ2021-10-29
1452201809480714K211873PSX Interbody SystemMAX2021-08-10
2954231809480714K211873PSX Interbody SystemMAX2021-08-10
1452201200038519K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody SystemMAX2021-09-22
2954231200038519K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody SystemMAX2021-09-22
1310442030233514K211300X-CUBE 90IYN2021-08-09
1310442060083744K211299X-CUBE 70IYN2021-08-09
1452201934513346K203742IdentiTi ALIF Standalone Interbody SystemOVD2021-04-09
2954231934513346K203742IdentiTi ALIF Standalone Interbody SystemOVD2021-04-09
1452201776434056K203125Invictus™ OCT Spinal Fixation SystemNKG2020-12-18
2954231776434056K203125Invictus™ OCT Spinal Fixation SystemNKG2020-12-18
1452201714386935K203056Invictus™ Spinal Fixation SystemNKB2020-11-23
2954231714386935K203056Invictus™ Spinal Fixation SystemNKB2020-11-23
1452201008946892K202812IdentiTi Cervical Standalone Interbody SystemOVE2020-12-18
2954231008946892K202812IdentiTi Cervical Standalone Interbody SystemOVE2020-12-18
1452201790207814K202587ATEC Lateral Interbody SystemMAX2020-11-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB442024-06-21
IYN342023-04-17
MAX322025-02-03
OLO252026-02-19
KWQ162025-08-28
KWP132011-06-02
GZL112025-03-30
MNI102011-02-08
GWF82026-01-11
OVD82025-09-03
MQP82023-10-06
ODP72025-07-03
MNH72009-04-29
NKG62020-12-18
FXX61989-02-14
PDQ42022-09-23
OVE42020-12-18
JAQ32024-07-10
KCT32012-05-04
OWI22026-03-25
OWB22024-05-22
PML22022-12-20
LLZ22021-10-29
PHM22016-09-08
MRW22012-11-28
DRF21998-04-20
DYG21997-02-03
DQO21993-01-14
IYO12012-07-26
MSH12009-10-21
JDK12005-10-05
DYB12000-06-16
LDF11994-01-28
HOY11988-03-21

NDC#

Oxygen

AlpinAire Healthcare

Oxygen

Oxygen

Alpine Medical, LLC

Oxygen

ZUNVEYL

Alpha Cognition, Inc.

benzgalantamine

ZUNVEYL

Alpha Cognition, Inc.

benzgalantamine

ZUNVEYL

Alpha Cognition, Inc.

benzgalantamine

PMN#

DeepXray

2023-09-08

Alpha Intelligence Manifolds, Inc.

200 records. Showing 1-40. Next

Applications#

68 records. Showing 1-40. Next