FDA Registration
Active
🇺🇸 United States
Medynus, Inc.
Reg #: 3015426608
·
FEI: 3015426608
·
Expires 2026
Products
4
Proprietary Names
235
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Medynus, Inc.
- Registration Number
- 3015426608
- FEI Number
- 3015426608
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 18 Technology Dr. Suite 109
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212792
Owner / Operator
- Firm Name
- Medynus, Inc.
- Operator Number
- 10060045
- Address
- 18 Technology Dr., Suite 109
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-10-27 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-10-27 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-06-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-07-16 |
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
T5 Screw Navigation Driver 3.5mm (OIN-01108)
Double Lead TAP 4.5mm (OIN-00008H)
CrossLink Fixation Driver (OIN-00033)
Guide Pin A (OIN-00004)
T30 MIS Screw Navigation Driver 5.5mm Locking (MIN-00106)
OPEN TYPE IMPLANTS CONTAINER (OTR-00001, AICN-1005-0004, and others)
T30 Open Screw Driver 5.5mm blue (OIN-00005A)
Caliper 30-120mm (MIN-00011)
Poly Screw Driver Reduction (OIN-00014)
Double Lead TAP 8mm (OIN-00012)
Double Lead TAP 5mm (OIN-00009)
Table Top Rod Cutter & Rod Bender 5.5mm (OIN-00221)
MIS Rod Inserter (MIN-00010)
K-Wire, D1.5mm x L480mm Uni-Thread TIP 1.5 * 480 mm (MIN-00104-480)
Open Set Screw Starter 5.5mm ball (OIN-00030S)
Compressor (OIN-00027)
Cannulated Quick Screw Driver (MIN-00006)
In-situ Bender (L) (OIN-00022)
T30 MIS Screw Driver 5.5mm (MIN-00005)
SLEEVE CUTTER (MIN-00013)
Cannulated 6 Tap (MIN-00003)
Mono Screw Driver ( Reduction ) (OIN-00016)
K-Wire, D1.5mm x L480mm Uni-Diamond TIP 1.5 * 480 mm (MIN-00102-480)
Rod Bender (OIN-00021)
Guide Pin B (OIN-00005)
T30 Reduction Screw Driver 5.5mm blue (OIN-01000)
Double Lead TAP 4mm (OIN-00008)
Quick Screw Driver (OIN-00017)
K-Wire, D1.5mm x L480mm ROUND TIP (Nitinol) (MIN-00001)
Table Top Wire Pin And Rod Cutter 70cm 5.5mm (OIN-00222)
K-Wire, D1.5mm x L500mm Bi-ROUND TIP 1.5 * 500 mm (MIN-00001-500)
Anti-Torque Device (OIN-00031)
T30 MIS Screw Navigation Driver 5.5mm (MIN-00105)
Reduction Sleeve Breaker (OIN-00032)
Rod Gripper (OIN-00020)
DILATOR, ID10 x OD14mm (MIN-00008)
K-Wire, D1.5mm x L480mm Bi-ROUND TIP 1.5 * 480 mm (MIN-00001-480)
K-Wire, D1.5mm x L550mm Bi-ROUND TIP 1.5 * 550 mm (MIN-00001-550)
T30 MIS Screw Driver 5.5mm blue (MIN-00005A)
Double Lead TAP 7mm (OIN-00011)
Pedicle Probe, CR (OIN-00003)
Open Set Screw Starter 5.5mm centerline (OIN-00030SS)
Pedicle Probe, ST (OIN-00002)
MIS Instrument Container (MTR-00002)
Cannulated Ratchet I-Handle (OIN-00040)
Ball Tip Tester, CR (OIN-00007)
LS Anti-Torque Device (MIN-00012)
Rod Fork 5.5 (OIN-00025)
DILATOR, ID1.8 x OD10mm (MIN-00007)
Cannulated 7 Tap (MIN-00004)
MIS Implant Container (MTR-00001)
MIS TYPE IMPLANTS CONTAINER (MTR-00001, AICN-1005-0003, and others)
Persuader 5.5mm (OIN-00026)
Ball Tip Tester Double End (OIN-00065)
T30 Open Screw Navigation Driver 5.5mm (OIN-00105)
T30 Reduction Screw Navigation Driver 5.5mm Locking (OIN-01105)
Torque Limit Handle, 13N (OIN-00043)
T30 Reduction Screw Navigation Driver 5.5mm (OIN-01105)
T30 Open Screw Navigation Driver 5.5mm Locking (OIN-00106)
Head Alignment (OIN-00018)
Coronal Bender (L) (OIN-00122)
K-Wire, D1.5mm x L480mm Bi-Threaded TIP 1.5 * 480 mm (MIN-00103-480)
Open Screw Instrument Container Type B (OTR-00003)
Coronal Bender ® (OIN-00123
Open Screw Implant Container (OTR-00001)
T30 Reduction Screw Power Driver 5.5mm (OIN-01104)
In-situ Bender ® (OIN-00023)
T30 Open Screw Driver 5.5mm (OIN-00013)
Ball Tip Tester, ST (OIN-00006)
Cannulated Ratchet T-handle, 1/4" Square (OIN-00041)
Open Screw Instrument Container Type A (OTR-00002)
Rod Pusher (OIN-00024)
Mono Screw Driver (OIN-00015)
AWL (OIN-00001)
CrossLink Driver (OIN-00034)
Rod Holder (OIN-00019)
K-Wire, D1.5mm x L480mm Bi-Diamond TIP 1.5 * 480 mm (MIN-00101-480)
T30 Set Screw Driver T30 (OIN-00030)
Cannulated 5 Tap (MIN-00002)
Double Lead TAP 6mm (OIN-00010)
Cannulated Ratchet Palm handle, 1/4" Square (OIN-00042)
DILATOR, ID14 x OD16mm (MIN-00009)
Set Screw Starter (OIN-00029)
Distractor (OIN-00028)
Curved MIS Rod Inserter (MIN-00107)
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198