FDA Registration
Active
🇺🇸 United States
Double Lead TAP 4.5mm (OIN-00008H)
Reg #: 3015426608
·
FEI: 3015426608
·
Expires 2025
Products
1
Proprietary Names
84
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Medynus, Inc.
- Registration Number
- 3015426608
- FEI Number
- 3015426608
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 18 Technology Dr. Suite 109
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210420
Owner / Operator
- Firm Name
- Medynus, Inc.
- Operator Number
- 10060045
- Address
- 18 Technology Dr. Suite 109
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Daewon Shin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-07-16 |
Proprietary Names
Double Lead TAP 4.5mm (OIN-00008H)
OPEN TYPE IMPLANTS CONTAINER (OTR-00001, AICN-1005-0004, and others)
Reduction Sleeve Breaker (OIN-00032)
MIS TYPE IMPLANTS CONTAINER (MTR-00001, AICN-1005-0003, and others)
Anti-Torque Device (OIN-00031)
MIS Implant Container (MTR-00001)
SLEEVE CUTTER (MIN-00013)
Cannulated 6 Tap (MIN-00003)
T30 MIS Screw Navigation Driver 5.5mm (MIN-00105)
CrossLink Driver (OIN-00034)
T30 Reduction Screw Navigation Driver 5.5mm (OIN-01105)
Open Screw Implant Container (OTR-00001)
Open Set Screw Starter 5.5mm ball (OIN-00030S)
Compressor (OIN-00027)
MIS Rod Inserter (MIN-00010)
Persuader 5.5mm (OIN-00026)
Pedicle Probe, ST (OIN-00002)
Cannulated Ratchet T-handle, 1/4" Square (OIN-00041)
Mono Screw Driver ( Reduction ) (OIN-00016)
In-situ Bender ® (OIN-00023)
K-Wire, D1.5mm x L480mm Bi-Diamond TIP 1.5 * 480 mm (MIN-00101-480)
Double Lead TAP 6mm (OIN-00010)
Quick Screw Driver (OIN-00017)
DILATOR, ID1.8 x OD10mm (MIN-00007)
MIS Instrument Container (MTR-00002)
Head Alignment (OIN-00018)
T30 MIS Screw Driver 5.5mm (MIN-00005)
LS Anti-Torque Device (MIN-00012)
AWL (OIN-00001)
Cannulated Ratchet I-Handle (OIN-00040)
Cannulated Ratchet Palm handle, 1/4" Square (OIN-00042)
Guide Pin B (OIN-00005)
Double Lead TAP 8mm (OIN-00012)
Double Lead TAP 5mm (OIN-00009)
Distractor (OIN-00028)
CrossLink Fixation Driver (OIN-00033)
T30 Reduction Screw Driver 5.5mm blue (OIN-01000)
Pedicle Probe, CR (OIN-00003)
Open Set Screw Starter 5.5mm centerline (OIN-00030SS)
Double Lead TAP 4mm (OIN-00008)
T30 Set Screw Driver T30 (OIN-00030)
Cannulated 5 Tap (MIN-00002)
K-Wire, D1.5mm x L480mm Uni-Diamond TIP 1.5 * 480 mm (MIN-00102-480)
Ball Tip Tester, ST (OIN-00006)
Open Screw Instrument Container Type B (OTR-00003)
K-Wire, D1.5mm x L480mm Bi-ROUND TIP 1.5 * 480 mm (MIN-00001-480)
K-Wire, D1.5mm x L480mm Uni-Thread TIP 1.5 * 480 mm (MIN-00104-480)
Mono Screw Driver (OIN-00015)
Ball Tip Tester, CR (OIN-00007)
T30 Open Screw Navigation Driver 5.5mm (OIN-00105)
Rod Pusher (OIN-00024)
T30 Reduction Screw Navigation Driver 5.5mm Locking (OIN-01105)
Set Screw Starter (OIN-00029)
K-Wire, D1.5mm x L480mm Bi-Threaded TIP 1.5 * 480 mm (MIN-00103-480)
T30 MIS Screw Driver 5.5mm blue (MIN-00005A)
Rod Fork 5.5 (OIN-00025)
Open Screw Instrument Container Type A (OTR-00002)
T30 Open Screw Driver 5.5mm blue (OIN-00005A)
DILATOR, ID10 x OD14mm (MIN-00008)
T30 Open Screw Navigation Driver 5.5mm Locking (OIN-00106)
In-situ Bender (L) (OIN-00022)
Cannulated 7 Tap (MIN-00004)
K-Wire, D1.5mm x L500mm Bi-ROUND TIP 1.5 * 500 mm (MIN-00001-500)
K-Wire, D1.5mm x L480mm ROUND TIP (Nitinol) (MIN-00001)
Coronal Bender ® (OIN-00123
Curved MIS Rod Inserter (MIN-00107)
T30 MIS Screw Navigation Driver 5.5mm Locking (MIN-00106)
Rod Gripper (OIN-00020)
T30 Open Screw Driver 5.5mm (OIN-00013)
Caliper 30-120mm (MIN-00011)
Ball Tip Tester Double End (OIN-00065)
Coronal Bender (L) (OIN-00122)
Poly Screw Driver Reduction (OIN-00014)
DILATOR, ID14 x OD16mm (MIN-00009)
Guide Pin A (OIN-00004)
T30 Reduction Screw Power Driver 5.5mm (OIN-01104)
Rod Bender (OIN-00021)
Cannulated Quick Screw Driver (MIN-00006)
Double Lead TAP 7mm (OIN-00011)
Torque Limit Handle, 13N (OIN-00043)
Rod Holder (OIN-00019)
K-Wire, D1.5mm x L550mm Bi-ROUND TIP 1.5 * 550 mm (MIN-00001-550)
Table Top Rod Cutter & Rod Bender 5.5mm (OIN-00221)
Table Top Wire Pin And Rod Cutter 70cm 5.5mm (OIN-00222)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198