FDA Registration
Active
🇰🇷 South Korea
T30 Open Screw Driver 5.5mm blue (OIN-00005A)
Reg #: 3021945817
·
FEI: 3021945817
·
Expires 2025
Products
1
Proprietary Names
82
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HO MEDI Co., Ltd
- Registration Number
- 3021945817
- FEI Number
- 3021945817
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ra, je1dong, 307-1 Chilbongsan-Ro
- City
- Yangju Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K210420
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
- David Daewon
- Address
- 18 Technology Dr Ste 109
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 9320847
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-02-09 |
Proprietary Names
T30 Open Screw Driver 5.5mm blue (OIN-00005A)
DILATOR, ID14 x OD16mm (MIN-00009)
T30 Reduction Screw Driver 5.5mm blue (OIN-01000)
Curved MIS Rod Inserter(MIN-00107)
Set Screw Starter (OIN-00029)
Head Alignment (OIN-00018)
Rod Holder (OIN-00019)
T30 Open Screw Navigation Driver 5.5mm Locking (OIN-00106)
K-Wire, D1.5mm x L550mm Bi-ROUND TIP 1.5 * 550 mm (MIN-00001-550)
T30 Reduction Screw Navigation Driver 5.5mm (OIN-01105)
Mono Screw Driver (OIN-00015)
Pedicle Probe, ST (OIN-00002)
Open Screw Implant Container (OTR-00001)
Caliper 30-120mm (MIN-00011)
LS Anti-Torque Device (MIN-00012)
Double Lead TAP 7mm (OIN-00011)
K-Wire, D1.5mm x L480mm Bi-Threaded TIP 1.5 * 480 mm (MIN-00103-480)
Double Lead TAP 4mm (OIN-00008)
Mono Screw Driver ( Reduction ) (OIN-00016)
Cannulated Quick Screw Driver (MIN-00006)
OPEN TYPE IMPLANTS CONTAINER (OTR-00001, AICN-1005-0004, and others)
Rod Pusher (OIN-00024)
T30 MIS Screw Navigation Driver 5.5mm Locking (MIN-00106)
Anti-Torque Device (OIN-00031)
Ball Tip Tester, CR (OIN-00007)
MIS Instrument Container (MTR-00002)
Cannulated Ratchet I-Handle (OIN-00040)
T30 Open Screw Driver 5.5mm (OIN-00013)
Reduction Sleeve Breaker (OIN-00032)
SLEEVE CUTTER (MIN-00013)
T30 MIS Screw Driver 5.5mm (MIN-00005)
MIS TYPE IMPLANTS CONTAINER (MTR-00001, AICN-1005-0003, and others)
DILATOR, ID1.8 x OD10mm (MIN-00007)
Open Screw Instrument Container Type A (OTR-00002)
Rod Gripper (OIN-00020)
T30 Set Screw Driver T30 (OIN-00030)
In-situ Bender ® (OIN-00023)
Cannulated 6 Tap (MIN-00003)
Ball Tip Tester Double End (OIN-00065)
K-Wire, D1.5mm x L480mm Uni-Thread TIP 1.5 * 480 mm (MIN-00104-480)
Guide Pin A (OIN-00004)
Distractor (OIN-00028)
Cannulated Ratchet Palm handle, 1/4" Square (OIN-00042)
In-situ Bender (L) (OIN-00022)
Open Set Screw Starter 5.5mm centerline (OIN-00030SS)
Double Lead TAP 5mm (OIN-00009)
CrossLink Fixation Driver (OIN-00033)
K-Wire, D1.5mm x L480mm ROUND TIP (Nitinol) (MIN-00001)
Compressor (OIN-00027)
MIS Implant Container (MTR-00001)
DILATOR, ID10 x OD14mm (MIN-00008)
Double Lead TAP 6mm (OIN-00010)
AWL (OIN-00001)
Open Screw Instrument Container Type B (OTR-00003)
K-Wire, D1.5mm x L480mm Bi-ROUND TIP 1.5 * 480 mm (MIN-00001-480)
Guide Pin B (OIN-00005)
Cannulated 5 Tap (MIN-00002)
Cannulated 7 Tap (MIN-00004)
CrossLink Driver (OIN-00034)
Coronal Bender ® (OIN-00123
Pedicle Probe, CR (OIN-00003)
T30 Open Screw Navigation Driver 5.5mm (OIN-00105)
Ball Tip Tester, ST (OIN-00006)
Rod Bender (OIN-00021)
Persuader 5.5mm (OIN-00026)
Cannulated Ratchet T-handle, 1/4" Square (OIN-00041)
Poly Screw Driver Reduction (OIN-00014)
Table Top Wire Pin And Rod Cutter 70cm 5.5mm (OIN-00222)
Table Top Rod Cutter & Rod Bender 5.5mm (OIN-00221)
Torque Limit Handle, 13N (OIN-00043)
K-Wire, D1.5mm x L480mm Uni-Diamond TIP 1.5 * 480 mm (MIN-00102-480)
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)
Open Set Screw Starter 5.5mm ball (OIN-00030S)
K-Wire, D1.5mm x L480mm Bi-Diamond TIP 1.5 * 480 mm (MIN-00101-480)
MIS Rod Inserter (MIN-00010)
Coronal Bender (L) (OIN-00122)
Double Lead 8 Tap (OIN-00012)
Rod Fork 5.5 (OIN-00025)
T30 MIS Screw Navigation Driver 5.5mm (MIN-00105)
T30 Reduction Screw Navigation Driver 5.5mm Locking (OIN-01105)
Quick Screw Driver (OIN-00017)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)