ProMIS Extension Rod System
Premia Spine, Ltd.
Premia Spine Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012452928 | 3012452928 | Premia Spine Inc | 1 | Y | 2026-01-01 | 11 Commerce St Norwalk CT US 06850 |
PMN#
ProMIS? Fixation System
Premia Spine, Ltd.
Premia Spine XL Instruments
Premia Spine, Ltd.
VersaLink™ Fixation System
Premia Spine Ltd.
ProMIS™ Fixation System
Premia Spine Ltd.
ProMIS Fixation System
Premia Spine Ltd.
GUDID#
ProMIS™ Fixation System - Pre Bent Rod Ø6.0x250mm Blunt Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
2026-05-25
ProMIS™ Fixation System - Pre Bent Rod Ø6.0x270 blunt edge The system is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
2026-05-25
Counter Torque ST - 83142N
2026-05-25
VersaLink Bender - 82584
2024-10-01
Rod Bender - 86297
2024-10-01
SST 316 LVM, L=470, Ø1.5 over the K-Wire - 87851
2024-09-05
K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA - 87302
2024-09-05
SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill - 87447
2024-09-05
SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique - 87209
2024-09-05
SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire - 87208
2024-09-05
SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked) - 87364
2024-09-05
SST 316 LVM, Blunt-Threaded Tip, L=470, Ø1.7 over the K-Wire - 86289
2024-09-05
SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-Wire - 86264
2024-09-05
K-Wire, Blunt Sharp Tip, L=230, Ø1.7mm Shidi-Tec 230 - 86828
2024-09-05
K-Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-Wire - 86830
2024-09-05
K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWA - 86864
2024-09-05
Niti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm Over K-Wire - 87009
2024-09-05
Niti#1 Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-Wire - 87010
2024-09-05
K-Wire, CrCo, Blunt Sharp Tip, L=340, Ø1.65mm DKWA - 87271
2024-09-05
Niti#1 Wire, Blunt Beveled Tip, L=470, Ø1.7mm Over K-Wire - 87359
2024-09-05
K-Wire, Blunt Sharp Tip, L=565, Ø1.6 -0.05 mm P.Drill - 87445
2024-09-05
K-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.Drill - 87696
2024-09-05
Niti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-Wire - 87865
2024-09-05
K-Wire, Blunt Beveled Tip, L=335,Ø 1.7 mm KWA - 88020
2024-09-05
Cannulated Tap Ø6.5 XL - 87150
2024-09-03
Cannulated Tap Ø5.5 XL - 87151
2024-09-03
Cannulated Tap Ø4.5 XL - 87152
2024-09-03
Pendulum - 82775
2024-09-03
K-Wire Adaptor - 86494
2024-09-03
Pedicle Awl XL - 87148
2024-09-03
Pedicle Probe XL - 87149
2024-09-03
Cannulated screwdriver XL - 87153
2024-09-03
Tube for XL instruments - 87259
2024-09-03
Straight Pedicle Probe XL - 87272
2024-09-03
Pedicle Awl- Conical - 81708
2024-09-01
Pedicle Probe Bent with Drop handle - 86676
2024-09-03
ProMIS™ Fixation System - Pre Bent Rod Ø6.0x65mm Blunt EdgeThe ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
2024-01-17
PER System 60 - 88989
2024-10-10
PER System 75 - 88990
2024-10-10
PER System 50 - 89012
2024-10-10