Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021945817

FEI Number

3021945817

Entity Name

HO MEDI Co., Ltd

City/State/Country

Yangju Gyeonggi, KR

Establishment Address

ra, je1dong, 307-1 Chilbongsan-Ro, Yangju Gyeonggi 11448, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HO MEDI (Owner Number: 10092686)

Owner / Operator Contact Address

RA, JE1Dong, 307-1, Chilbongsan-ro, Yangju-si, KR-41 11448, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mono Screw Driver ( Reduction ) (OIN-00016) Cannulated Quick Screw Driver (MIN-00006) K-Wire, D1.5mm x L550mm Bi-ROUND TIP 1.5 * 550 mm (MIN-00001-550) Double Lead 8 Tap (OIN-00012) Rod Fork 5.5 (OIN-00025) DILATOR, ID1.8 x OD10mm (MIN-00007) Rod Gripper (OIN-00020) MIS Instrument Container (MTR-00002) T30 MIS Screw Navigation Driver 5.5mm Locking (MIN-00106) Cannulated 5 Tap (MIN-00002) Ball Tip Tester, ST (OIN-00006) Cannulated 7 Tap (MIN-00004) CrossLink Driver (OIN-00034) Double Lead TAP 5mm (OIN-00009) K-Wire, D1.5mm x L480mm Uni-Diamond TIP 1.5 * 480 mm (MIN-00102-480) Guide Pin B (OIN-00005) T30 MIS Screw Navigation Driver 5.5mm (MIN-00105) T30 Reduction Screw Navigation Driver 5.5mm Locking (OIN-01105) Pedicle Probe, CR (OIN-00003) T30 Open Screw Navigation Driver 5.5mm (OIN-00105) Rod Pusher (OIN-00024) Set Screw Starter (OIN-00029) Head Alignment (OIN-00018) Rod Holder (OIN-00019) Torque Limit Handle, 13N (OIN-00043) Coronal Bender ® (OIN-00123 DILATOR, ID10 x OD14mm (MIN-00008) Double Lead TAP 6mm (OIN-00010) Open Set Screw Starter 5.5mm centerline (OIN-00030SS) CrossLink Fixation Driver (OIN-00033) K-Wire, D1.5mm x L480mm Uni-Thread TIP 1.5 * 480 mm (MIN-00104-480) DILATOR, ID14 x OD16mm (MIN-00009) T30 Reduction Screw Driver 5.5mm blue (OIN-01000) T30 Set Screw Driver T30 (OIN-00030) In-situ Bender ® (OIN-00023) Cannulated Ratchet I-Handle (OIN-00040) Table Top Rod Cutter & Rod Bender 5.5mm (OIN-00221) Distractor (OIN-00028) Persuader 5.5mm (OIN-00026) Cannulated Ratchet Palm handle, 1/4" Square (OIN-00042) K-Wire, D1.5mm x L480mm Bi-Diamond TIP 1.5 * 480 mm (MIN-00101-480) MIS Rod Inserter (MIN-00010) MIS TYPE IMPLANTS CONTAINER (MTR-00001, AICN-1005-0003, and others) Mono Screw Driver (OIN-00015) Pedicle Probe, ST (OIN-00002) T30 Open Screw Driver 5.5mm blue (OIN-00005A) Guide Pin A (OIN-00004) OPEN TYPE IMPLANTS CONTAINER (OTR-00001, AICN-1005-0004, and others) Cannulated 6 Tap (MIN-00003) T30 Open Screw Navigation Driver 5.5mm Locking (OIN-00106) Ball Tip Tester Double End (OIN-00065) Rod Bender (OIN-00021) Open Set Screw Starter 5.5mm ball (OIN-00030S) T30 Open Screw Driver 5.5mm (OIN-00013) Reduction Sleeve Breaker (OIN-00032) Cannulated Ratchet T-handle, 1/4" Square (OIN-00041) K-Wire, D1.5mm x L500mm Bi-ROUND TIP 1.5 * 500 mm (MIN-00001-500) T30 MIS Screw Driver 5.5mm blue (MIN-00005A) K-Wire, D1.5mm x L480mm ROUND TIP (Nitinol) (MIN-00001) Compressor (OIN-00027) MIS Implant Container (MTR-00001) Caliper 30-120mm (MIN-00011) LS Anti-Torque Device (MIN-00012) In-situ Bender (L) (OIN-00022) Open Screw Implant Container (OTR-00001) AWL (OIN-00001) Open Screw Instrument Container Type B (OTR-00003) Quick Screw Driver (OIN-00017) Anti-Torque Device (OIN-00031) Ball Tip Tester, CR (OIN-00007) Curved MIS Rod Inserter(MIN-00107) Double Lead TAP 7mm (OIN-00011) K-Wire, D1.5mm x L480mm Bi-Threaded TIP 1.5 * 480 mm (MIN-00103-480) Coronal Bender (L) (OIN-00122) T30 Reduction Screw Navigation Driver 5.5mm (OIN-01105) Double Lead TAP 4mm (OIN-00008) Open Screw Instrument Container Type A (OTR-00002) K-Wire, D1.5mm x L480mm Bi-ROUND TIP 1.5 * 480 mm (MIN-00001-480) Poly Screw Driver Reduction (OIN-00014) Table Top Wire Pin And Rod Cutter 70cm 5.5mm (OIN-00222) SLEEVE CUTTER (MIN-00013) T30 MIS Screw Driver 5.5mm (MIN-00005) Trial Lordotic 14*16*11mm (CCN-00015) Bone Curette(Reverse 3mm) (END-CUR3M) Serial Dilator 3 (END-SD003) Trial Lordotic dual 12*14*11-12mm Trial Anatomic dual 12*14*9-10mm Cervical Cage impactor (CCN-00052) Mallet (END-MA001) Trial Lordotic 14*16*5mm (CCN-00009) Rotator Kerrison Curved Head(2mm) (END-RKCH2) Dilator (END-MD001) UV Retractor(100mm) (END-WT100) UV Retractor(50mm) (END-WT050) UV Retractor(90mm) (END-WT090) Trial Anatomic dual 12*14*5-6mm Trial Anatomic 12*14*5mm (CCN-00017) Trial Anatomic 14*16*9mm (CCN-00029) Rotator Kerrison Curved Head(3mm) (END-RKCH3) Trial Lordotic 12*14*5mm (CCN-00001) Trial Lordotic 12*14*12mm (CCN-00008) Trial Lordotic 14*16*12mm (CCN-00016) Trial Lordotic dual 12*14*5-6mm Micro Pituitary(Straight) (END-MPS2M) Freer (END-PF001) Indian Knife (END-DK001) UV Retractor(40mm) (END-WT040) Root Retractor (END-RR001) Trial Lordotic 14*16*7mm (CCN-00011) Trial Anatomic 14*16*6mm (CCN-00026) Trial Anatomic 14*16*7mm (CCN-00027) Pedicle Chisel(5mm) (END-OTP5M) Chisel(Stright 5mm) (END-OTS5M) Trial Anatomic 14*16*10mm (CCN-00030) Trial Anatomic 12*14*11mm (CCN-00023) Bone Curette(3mm) (END-CU05M) Trial Anatomic 12*14*12mm (CCN-00024) Trial Anatomic dual 12*14*11-12mm UV Retractor(80mm) (END-WT080) Rotator Kerrison Head(3mm) (END-RKSH3) Trial Lordotic dual 12*14*9-10mm Curved Kerrison 2mm (END-CK02M) Verana (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage and Instrument sets including its containers Trial Lordotic 12*14*7mm (CCN-00003) Trial Lordotic dual 14*16*11-12mm Trial Anatomic 12*14*6mm (CCN-00018) Trial Anatomic dual 14*16*7-8mm Trial Lordotic 12*14*6mm (CCN-00002) Trial Anatomic dual 14*16*11-12mm Cervical Cage holder (CCN-00051) CERVICAL CAGE IMPLANTS CONTAINER (CCT-00001, AICN-1005-0001, and others) Cervical Cage bone impactor (CCN-00053) Trial Lordotic 14*16*8mm (CCN-00012) Hockey Chisel(Right 5mm) (END-OTR5M) Trial Anatomic dual 14*16*9-10mm Hockey Chisel(Left 5mm) (END-OTL5M) Trial Lordotic 12*14*9mm (CCN-00005) Trial Anatomic dual 14*16*5-6mm Trial Lordotic dual 12*14*7-8mm Trial Lordotic dual 14*16*5-6mm Cervical Cage Lordotic Implant Caddy (CNR-00002) Trial Anatomic 14*16*12mm (CCN-00032) Curved Kerrison 3mm (END-CK03M) Rotator Kerrison Head(2mm) (END-RKSH2) Trial Lordotic 14*16*9mm (CCN-00013) Trial Lordotic 12*14*10mm (CCN-00006) Micro Pituitary(Up) (END-MPU2M) Serial Dilator 4 (END-SD004) UV Retractor(70mm) (END-WT070) Trial Anatomic 14*16*11mm (CCN-00031 Trial Anatomic 14*16*5mm (CCN-00025) Cervical Cage Container (CCT-00001) Trial Lordotic dual 14*16*9-10mm Trial Lordotic 14*16*10mm (CCN-00014) Trial Lordotic 12*14*8mm (CCN-00004) BESS Tray with Lid (END-TR001) Trial Anatomic dual 12*14*7-8mm Spinal Cord Retractor Curved (END-SCRC1) Rotator Kerrison Handle (END-RKH01) Trial Anatomic 12*14*10mm (CCN-00022) Trial Lordotic dual 14*16*7-8mm Trial Anatomic 14*16*8mm (CCN-00028) Cervical Cage Anatomic Implant Caddy (CNR-00003) Bone Curette(5mm) (END-CU03M) Boomerang Curette(3mm) (END-CUB3M) Serial Dilator 2 (END-SD002) Serial Dilator 1 (END-SD001) Bone Curette(5mm) (END-CU06M) Trial Anatomic 12*14*9mm (CCN-00021) Pixie (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage UV Retractor(60mm) (END-WT060) Trial Lordotic 12*14*11mm (CCN-00007) Spinal Cord Retractor Straight (END-SCRS1) Trial Lordotic 14*16*6mm (CCN-00010) Trial Anatomic 12*14*8mm (CCN-00020)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-02-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-02-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-02-09

Official Correspondent

MINSU KIM

US Agent Details

Kayla Kim Business: MEDYNUS INC Email: ra@medynus.com Phone: (213) 2576646

Related Public Records

Same Entity

HO MEDI

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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

Similar Registrations

Registration Number	Establishment Name	Location
3043234953	ALLUMIN8 INC	Springfield, MO, US
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3004635447	C&W SWISS, INC.	CLAYTON, OH, US
3015869493	Jabil Switzerland Manufacturing GmbH (Mezzovico)	Mezzovico Ticino, CH
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021945817. Last updated year: 2026. Please use registration number 3021945817 when referencing this establishment in official correspondence.