Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015426608

FEI Number

3015426608

Entity Name

Medynus, Inc.

City/State/Country

Irvine, CA, US

Establishment Address

18 Technology Dr. Suite 109, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Medynus, Inc. (Owner Number: 10060045)

Owner / Operator Contact Address

18 Technology Dr., Suite 109, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220379

PMA Number

N/A

All Registered Proprietary Names

Pixie (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage Trial Anatomic 12*14*5mm (CCN-00017) Trial Anatomic 12*14*7mm (CCN-00019) Trial Lordotic dual 14*16*7-8mm Trial Anatomic 12*14*8mm (CCN-00020) Trial Anatomic 12*14*10mm (CCN-00022) Trial Lordotic 14*16*5mm (CCN-00009) Trial Lordotic 14*16*11mm (CCN-00015) Trial Lordotic 14*16*12mm (CCN-00016) Trial Lordotic dual 12*14*11-12mm Cervical Cage Container (CCT-00001) Trial Lordotic 14*16*9mm (CCN-00013) Trial Lordotic 12*14*12mm (CCN-00008) Trial Anatomic dual 14*16*5-6mm Trial Lordotic 12*14*5mm (CCN-00001) Trial Lordotic 14*16*7mm (CCN-00011) Trial Anatomic 14*16*11mm (CCN-00031 Trial Anatomic 14*16*8mm (CCN-00028) Trial Lordotic 12*14*9mm (CCN-00005) Trial Anatomic dual 14*16*7-8mm Trial Anatomic dual 14*16*11-12mm Trial Lordotic dual 14*16*5-6mm Trial Anatomic 14*16*9mm (CCN-00029) Trial Lordotic 14*16*10mm (CCN-00014) Trial Anatomic 12*14*6mm (CCN-00018) Cervical Cage Anatomic Implant Caddy (CNR-00003) Boomerang Curette(3mm) (END-CUB3M) BESS Tray with Lid (END-TR001) Trial Lordotic dual 14*16*11-12mm Trial Lordotic 12*14*7mm (CCN-00003) Trial Lordotic 14*16*6mm (CCN-00010) Rotator Kerrison Curved Head(3mm) (END-RKCH3) Rotator Kerrison Head(3mm) (END-RKSH3) Micro Pituitary(Up) (END-MPU2M) Spinal Cord Retractor Curved (END-SCRC1) Dilator (END-MD001) CCN-00014 (AC.2110) ACDF Trial (Lordotic) L14 x W14 x A7 x H10 Trial Anatomic dual 12*14*9-10mm Trial Lordotic 12*14*8mm (CCN-00004) Indian Knife (END-DK001) Bone Curette(Reverse 3mm) (END-CUR3M) Root Retractor (END-RR001) CCN-00006 (AC.2094) ACDF Trial (Lordotic) L12 x W14 x A7 x H10 Trial Anatomic dual 12*14*5-6mm Trial Anatomic 12*14*9mm (CCN-00021) CCN-00011 (AC.2107) ACDF Trial (Lordotic) L14 x W14 x A7 x H7 UV Retractor(70mm) (END-WT070) Hockey Chisel(Right 5mm) (END-OTR5M) Serial Dilator 4 (END-SD004) CCN-00004 (AC.2092) ACDF Trial (Lordotic) L12 x W14 x A7 x H8 CCN-00005(AC.2093) ACDF Trial (Lordotic) L12 x W14 x A7 x H9 Trial Anatomic dual 12*14*7-8mm UV Retractor(90mm) (END-WT090) Spinal Cord Retractor Straight (END-SCRS1) Mallet (END-MA001) Trial Lordotic 12*14*11mm (CCN-00007) Trial Lordotic dual 12*14*9-10mm Curved Kerrison 2mm (END-CK02M) CCN-00012 (AC.2108) ACDF Trial (Lordotic) L14 x W14 x A7 x H8 Cervical Cage holder (CCN-00051) Trial Anatomic 14*16*12mm (CCN-00032) Trial Lordotic dual 12*14*7-8mm CCN-00049 (AC401) Cage holder inner shaft Curved Kerrison 3mm (END-CK03M) Micro Pituitary(Straight) (END-MPS2M) Bone Curette(5mm) (END-CU06M) Rotator Kerrison Curved Head(2mm) (END-RKCH2) Serial Dilator 2 (END-SD002) Trial Lordotic dual 12*14*5-6mm Trial Anatomic 14*16*6mm (CCN-00026) CCN-00052 (AC300) Cervical Cage impactor Chisel(Stright 5mm) (END-OTS5M) Freer (END-PF001) Trial Anatomic 14*16*5mm (CCN-00025) Cervical Cage bone impactor (CCN-00053) Bone Curette(3mm) (END-CU05M) Pedicle Chisel(5mm) (END-OTP5M) Trial Anatomic dual 12*14*11-12mm Trial Lordotic 14*16*8mm (CCN-00012) Cervical Cage Lordotic Implant Caddy (CNR-00002) Trial Lordotic 12*14*10mm (CCN-00006) CERVICAL CAGE IMPLANTS CONTAINER (CCT-00001, AICN-1005-0001, and others) Trial Anatomic 12*14*12mm (CCN-00024) UV Retractor(80mm) (END-WT080) Trial Anatomic 14*16*10mm (CCN-00030) CCN-00002 (AC.2090) ACDF Trial (Lordotic) L12 x W14 x A7 x H6 CCN-00013 (AC.2109) ACDF Trial (Lordotic) L14 x W14 x A7 x H9 Trial Lordotic dual 14*16*9-10mm UV Retractor(50mm) (END-WT050) Trial Anatomic 14*16*7mm (CCN-00027) Trial Anatomic 12*14*11mm (CCN-00023) Trial Lordotic 12*14*6mm (CCN-00002) Cervical Cage impactor (CCN-00052) Trial Anatomic dual 14*16*9-10mm Hockey Chisel(Left 5mm) (END-OTL5M) CCN-00051 (AC400) Cervical Cage holder UV Retractor(60mm) (END-WT060) UV Retractor(100mm) (END-WT100) UV Retractor(40mm) (END-WT040) Serial Dilator 1 (END-SD001) Rotator Kerrison Head(2mm) (END-RKSH2) CCN-00001 (AC.2089) ACDF Trial (Lordotic) L12 x W14 x A7 x H5 CCN-00009 (AC.2105) ACDF Trial (Lordotic) L14 x W14 x A7 x H5 CCN-00003 (AC.2091) ACDF Trial (Lordotic) L12 x W14 x A7 x H7 Verana (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage and Instrument sets including its containers CCN-00010 (AC.2106) ACDF Trial (Lordotic) L14 x W14 x A7 x H6 Rotator Kerrison Handle (END-RKH01) Serial Dilator 3 (END-SD003) Bone Curette(5mm) (END-CU03M) Cervical Plate Container (CPT-00001) Drill bit 16 (CPN-00008) Drill bit 18 (CPN-00009) Prefixation Pin (CPN-00001) Drill bit 20 (CPN-00010) Cervical Plate 3 level Implant Caddy (CPR-00005) Cervical Plate tap (CPN-00004) Cervical Plate 5 level Implant Caddy (CPR-00007) Fixed Awl (CPN-00003) Drill Guide Dual (CPN-00013) Drill Guide Variable (CPN-00011) Cervical Plate 1 level Implant Caddy (CPR-00003) Plate holder (CPN-00015) Cervical plate screw driver ball (CPN-00017) CPN-00015 (TP.IN002) Plate holder CPN-00001 Temporary Fixation pin CPN-00002 (TP.IN012) Cervical Punch Awl with Sleeve CPN-00016 (TP.IN003) Plate bender CPN-00006 (TP.IN007) Drill bit - 12 mm Plate bender (CPN-00016) CPN-00007 (TP.IN008) Drill bit - 14 mm Cervical Plate Screw Implant Caddy (CPR-00002) Drill bit 14 (CPN-00007) Punch Awl (CPN-00002) Drill bit 10 (CPN-00005) Cervical Plate 4 level Implant Caddy (CPR-00006) Drill Guide Fixed (CPN-00012) CPN-00012 (TP.IN005) Fixed pre-set angle Drill Guide (single barrel) CPN-00017 (CD.TP.IN014) Cervical plate screw driver ball shaft TP.IN012 Gervical Awl Cervical Plate 2 level Implant Caddy (CPR-00004) Cervical plate screw driver centerline (CPN-00018) CPN-00014( CD.TP.IN005) A-O Quick Connect Handle, Swivel_Short Type Modular I handle for Cervical (CPN-00014) CERVICAL PLATE IMPLANTS CONTAINER (CPT-00001, AICN-1005-0002, and others) Cervical plate torque limit driver (CPN-00019) CPN-00011 (TP.IN004) Variable angle Drill Guide (single barrel)-like Uniplate Drill bit 12 (CPN-00006) CPN-00005 (TP.IN006) Drill bit - 10 mm CCN-00053 (AC100) Cervical Bone packing bar CPN-00003 (TP.IN013) Cervical Fixed Awl, for Drill Guide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-10-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-10-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-06-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medynus, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

Similar Registrations

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3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015426608. Last updated year: 2026. Please use registration number 3015426608 when referencing this establishment in official correspondence.