This page includes the latest FDA filings for Premia Spine L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3012401682 |
| FEI Number | 3012401682 |
| Name | Jeff Withrow |
| Owner & Operator | Premia Spine Ltd. |
| Contact Address | Giborey Israel 7 Ramat Poleg, Netanya IL-M HaMerkaz 42504 IL |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 98 East Avenue Norwalk, CT 06851 US |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3012452928 |
| FEI Number | 3012452928 |
| Name | Premia Spine Inc |
| Owner & Operator | Premia Spine Ltd. |
| Contact Address | Giborey Israel 7 Ramat Poleg, Netanya IL-M HaMerkaz 42504 IL |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 98 East Avenue Norwalk, CT 06851 US |
Device Company | Device | Date |
|---|---|---|
| PREMIA SPINE LTD | K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA | 2025-09-17 |
| PREMIA SPINE LTD | SST 316 LVM, L=470, Ø1.5 over the K-Wire | 2025-09-17 |
| PREMIA SPINE LTD | K-Wire, Blunt Beveled Tip, L=335,Ø 1.7 mm KWA | 2025-09-16 |
| PREMIA SPINE LTD | Niti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | K-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.Drill | 2025-09-16 |
| PREMIA SPINE LTD | K-Wire, Blunt Sharp Tip, L=565, Ø1.6 -0.05 mm P.Drill | 2025-09-16 |
| PREMIA SPINE LTD | Niti#1 Wire, Blunt Beveled Tip, L=470, Ø1.7mm Over K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | K-Wire, CrCo, Blunt Sharp Tip, L=340, Ø1.65mm DKWA | 2025-09-16 |
| PREMIA SPINE LTD | Niti#1 Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | Niti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm Over K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWA | 2025-09-16 |
| PREMIA SPINE LTD | K-Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | K-Wire, Blunt Sharp Tip, L=230, Ø1.7mm Shidi-Tec 230 | 2025-09-16 |
| PREMIA SPINE LTD | SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | SST 316 LVM, Blunt-Threaded Tip, L=470, Ø1.7 over the K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked) | 2025-09-16 |
| PREMIA SPINE LTD | SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire | 2025-09-16 |
| PREMIA SPINE LTD | SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique | 2025-09-16 |
| PREMIA SPINE LTD | SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill | 2025-09-16 |
| PREMIA SPINE LTD | Distractor | 2024-10-18 |
| PREMIA SPINE LTD | PER System 50 | 2024-10-18 |
| PREMIA SPINE LTD | PER System 75 | 2024-10-18 |
| PREMIA SPINE LTD | PER System 60 | 2024-10-18 |
| PREMIA SPINE LTD | Versalink Torque Limiter | 2024-10-09 |
| PREMIA SPINE LTD | VersaLink Rod Inserter | 2024-10-09 |
| PREMIA SPINE LTD | VersaLink Monitor | 2024-10-09 |
| PREMIA SPINE LTD | Rod Cutter for 6mm | 2024-10-09 |
| PREMIA SPINE LTD | Rod Pusher | 2024-10-09 |
| PREMIA SPINE LTD | UNIFLEX Fork Persuader | 2024-10-09 |
| PREMIA SPINE LTD | Distractor for Open Procedure | 2024-10-09 |
| PREMIA SPINE LTD | Rod Bender | 2024-10-09 |
| PREMIA SPINE LTD | Cutting Guide | 2024-10-09 |
| PREMIA SPINE LTD | Compressor | 2024-10-09 |
| PREMIA SPINE LTD | Rod Holding Forceps Self Retaining | 2024-10-09 |
| PREMIA SPINE LTD | Rod Pusher | 2024-10-09 |
| PREMIA SPINE LTD | Compressor for Open Procedure | 2024-10-09 |
| PREMIA SPINE LTD | K-Wire, Blunt Sharp Tip, L=284, Ø1.7mm Short screwdriver+ KWA | 2024-10-09 |
| PREMIA SPINE LTD | K -Wire, Cr Co, Blunt Sharp Tip, L=289, Ø1.65mm Short screwdriver+ DKWA | 2024-10-09 |
| PREMIA SPINE LTD | Tower - Short Windows | 2024-10-09 |
| PREMIA SPINE LTD | Swiveling Sleeve | 2024-10-09 |
| PREMIA SPINE LTD | Head Release with Silicone Handle | 2024-10-09 |
| PREMIA SPINE LTD | Cannulated STR Silicone Handle with Push Coupling | 2024-10-09 |
| PREMIA SPINE LTD | Cannulated T- Silicone Handle with Push Coupling | 2024-10-09 |
| PREMIA SPINE LTD | Depth Gauge Tube for screw length | 2024-10-09 |
| PREMIA SPINE LTD | Feeler Gauge - Thick | 2024-10-09 |
| PREMIA SPINE LTD | Feeler Gauge - Thin | 2024-10-09 |
| PREMIA SPINE LTD | Curved Distractor | 2024-10-09 |
| PREMIA SPINE LTD | Straight Handle with Pendulum Adaptor w/o Ratchet | 2024-10-09 |
| PREMIA SPINE LTD | Quick Reduction Tool | 2024-10-09 |
| PREMIA SPINE LTD | Measuring Tube for Pedicle Screw Depth Assy. | 2024-10-09 |
| PREMIA SPINE LTD | Reduction Torque Handle with Extension | 2024-10-09 |
| PREMIA SPINE LTD | MIS Reduction Torque Handle | 2024-10-09 |
| PREMIA SPINE LTD | Reduction Tool Setscrew Inserter | 2024-10-09 |
| PREMIA SPINE LTD | MIS Reduction Tool Knob | 2024-10-09 |
| PREMIA SPINE LTD | MIS Reduction Tool Tower Connector | 2024-10-09 |
| PREMIA SPINE LTD | MIS reduction Tool reducer | 2024-10-09 |
| PREMIA SPINE LTD | Rod Inserter | 2024-10-09 |
| PREMIA SPINE LTD | Curved Pedicle Probe | 2024-10-09 |
| PREMIA SPINE LTD | MIS Compressor | 2024-10-09 |
| PREMIA SPINE LTD | Distractor | 2024-10-09 |
| PREMIA SPINE LTD | Rod Length Measurement Tool | 2024-10-09 |
| PREMIA SPINE LTD | Hammering Sleeve | 2024-10-09 |
| PREMIA SPINE LTD | Towers Alignment Tool | 2024-10-09 |
| PREMIA SPINE LTD | Depth Gauge | 2024-10-09 |
| PREMIA SPINE LTD | External Dilator | 2024-10-09 |
| PREMIA SPINE LTD | Middle Dilator | 2024-10-09 |
| PREMIA SPINE LTD | Inner Dilator | 2024-10-09 |
| PREMIA SPINE LTD | Ratchet T Handle | 2024-10-09 |
| PREMIA SPINE LTD | Torque Limiter | 2024-10-09 |
| PREMIA SPINE LTD | VersaLink Nut Torque Wrench | 2024-10-09 |
| PREMIA SPINE LTD | VersaLink Torque Limiter | 2024-10-09 |
| PREMIA SPINE LTD | VersaLink Rod Inserter | 2024-10-09 |
| PREMIA SPINE LTD | VersaLink Bender | 2024-10-09 |
| PREMIA SPINE LTD | Versalink Nut Counter Torque | 2024-10-09 |
| PREMIA SPINE LTD | Ring Nut Loading Base | 2024-10-09 |
| PREMIA SPINE LTD | Ring Nut Inserter | 2024-10-09 |
| PREMIA SPINE LTD | Alignment Gauge handle Long | 2024-09-11 |
| PREMIA SPINE LTD | Left Alignment Gauge Superior Crossbars Long | 2024-09-11 |
| PREMIA SPINE LTD | Right Alignment Gauge Superior Crossbars Long | 2024-09-11 |
| PREMIA SPINE LTD | TOPS Loading Base | 2024-09-11 |
| PREMIA SPINE LTD | TOPS Instrumentation Container | 2024-09-11 |
| PREMIA SPINE LTD | Cannulated Screwdriver | 2024-09-11 |
| PREMIA SPINE LTD | Torx Setscrew Inserter | 2024-09-11 |
| PREMIA SPINE LTD | MIS Cannulated Pedicle Probe | 2024-09-11 |
| PREMIA SPINE LTD | Standard Screwdriver | 2024-09-11 |
| PREMIA SPINE LTD | Counter Torque | 2024-09-11 |
| PREMIA SPINE LTD | Pendulum | 2024-09-11 |
| PREMIA SPINE LTD | Ball Probe | 2024-09-11 |
| PREMIA SPINE LTD | Ball Sleeve Assy | 2024-09-11 |
| PREMIA SPINE LTD | TOPS Inserter | 2024-09-11 |
| PREMIA SPINE LTD | Head Releaser | 2024-09-11 |
| PREMIA SPINE LTD | Cannulated Tap Ø4.5 XL | 2024-09-11 |
| PREMIA SPINE LTD | Cannulated Tap Ø5.5 XL | 2024-09-11 |
| PREMIA SPINE LTD | Cannulated Tap Ø6.5 XL | 2024-09-11 |
| PREMIA SPINE LTD | Cannulated Tap Ø 6.5 mm | 2024-09-11 |
| PREMIA SPINE LTD | Cannulated Tap Ø 5.5 mm | 2024-09-11 |
| PREMIA SPINE LTD | Cannulated Tap Ø 4.5 mm | 2024-09-11 |
| PREMIA SPINE LTD | Tap Ø 4.5 for Pendulum Adaptor | 2024-09-11 |
| PREMIA SPINE LTD | Tap Ø 6.5 for Pendulum Adaptor | 2024-09-11 |
| PREMIA SPINE LTD | Tap Ø 5.5 for Pendulum Adaptor | 2024-09-11 |
Premia Spine, Ltd. | Premia Spine XL Instruments | 2019-10-08 |
Jeff Withrow [Premia Spine Ltd.] | VersaLink? Fixation System | 2019-07-14 |
Premia Spine Ltd. | VersaLink™ Fixation System | 2018-11-13 |
Premia Spine Ltd. | ProMIS™ Fixation System | 2017-02-02 |
Jeff Withrow [Premia Spine Ltd.] | ProMIS? Fixation System | 2015-11-02 |
Jeff Withrow [Premia Spine Ltd.] | ProMIS? Fixation System | 2015-11-02 |
Jeff Withrow [Premia Spine Ltd.] | ProMIS? Fixation System | 2015-11-02 |
Premia Spine Ltd. | ProMIS Fixation System | 2015-07-17 |