FDA Registration
Active
🇰🇷 South Korea
HO MEDI Co., Ltd
Reg #: 3021945817
·
FEI: 3021945817
·
Expires 2026
Products
4
Proprietary Names
202
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HO MEDI Co., Ltd
- Registration Number
- 3021945817
- FEI Number
- 3021945817
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ra, je1dong, 307-1 Chilbongsan-Ro
- City
- Yangju Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- HO MEDI
- Operator Number
- 10092686
- Address
- RA, JE1Dong, 307-1, Chilbongsan-ro
- City
- Yangju-si
- State
- Gyeonggi
- Postal Code
- 11448
- Country
- KR
- Correspondent
- MINSU KIM
US Agent
- Business Name
- MEDYNUS INC
- Contact Name
- Kayla Kim
- Address
- 18 Technology Dr Ste 109
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 213 2576646
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-02-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-02-09 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-02-09 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-02-09 |
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)
Cervical Plate Screw Implant Caddy (CPR-00002)
Drill Guide Dual (CPN-00013)
Drill Guide Variable (CPN-00011)
Cervical plate screw driver ball (CPN-00017)
Cervical Plate tap (CPN-00004)
Cervical Plate 4 level Implant Caddy (CPR-00006)
Drill Guide Fixed (CPN-00012)
Plate bender (CPN-00016)
Drill bit 10 (CPN-00005)
Cervical Plate Container (CPT-00001)
CERVICAL PLATE IMPLANTS CONTAINER (CPT-00001, AICN-1005-0002, and others)
Fixed Awl (CPN-00003)
Drill bit 18 (CPN-00009)
Drill bit 20 (CPN-00010)
Cervical Plate 1 level Implant Caddy (CPR-00003)
Plate holder (CPN-00015)
Drill bit 14 (CPN-00007)
Modular I handle for Cervical (CPN-00014)
Cervical Plate 3 level Implant Caddy (CPR-00005)
Cervical plate torque limit driver (CPN-00019)
Cervical Plate 2 level Implant Caddy (CPR-00004)
Cervical Plate 5 level Implant Caddy (CPR-00007)
Drill bit 12 (CPN-00006)
Punch Awl (CPN-00002)
Drill bit 16 (CPN-00008)
Prefixation Pin (CPN-00001)
Cervical plate screw driver centerline (CPN-00018)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)