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PREMIA SPINE LTD

Last updated May 23, 2026

What PREMIA SPINE LTD makes

Premia Spine Ltd manufactures spinal fixation hardware, including cannulated and polyaxial pedicle screws, internal spinal rods, and reusable surgical instruments like guidewires, taps, and distraction tools. Their portfolio also includes reusable orthopaedic and ENT probes, as well as positioning instruments for prosthesis implantation. The company produces torque-limited screwdrivers and reusable surgical handles for spinal and orthopaedic procedures.

The company’s devices are classified under FDA regulations as Class II and Class III, with all products listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 649220779

Catalogue (452)

Page 6 of 10

Device	Model / Reference	Registries	Class	Status
VersaLink™ Fixation System	86278	FDA UDI	Class II	Active
VersaLink™ Fixation System	82883	FDA UDI	Class II	Active
Polyaxial Pedicle Screw	86120	FDA UDI	Class II	Active
Cannulated Tapered Pedicle Screw	88690	FDA UDI	Class II	Active
VersaLink™ Fixation System	87531	FDA UDI	Class II	Active
Tops™ - 30 L	82644	FDA UDI	Class III	Active
ProMIS™ Fixation System	87680	FDA UDI	Class II	Active
Tube for K-wire Tapshidi/Jamshidi Technique 230mm	86820	FDA UDI	Class II	Active
ProMIS™ Fixation System	87500	FDA UDI	Class II	Active
K-Wire, Blunt Beveled Tip, L=335, Ø 1.7 mm KWA	88020	FDA UDI	Class III	Active
Counter Torque	83142	FDA UDI	Class II	Active
ProMIS™ Fixation System	87683	FDA UDI	Class II	Active
ProMIS™ Fixation System	87477	FDA UDI	Class II	Active
Cannulated Tapered Pedicle Screw	88676	FDA UDI	Class II	Active
Non-Cannulated Polyaxial Pedicle Screw	88521	FDA UDI	Class II	Active
VersaLink™ Fixation System	86164	FDA UDI	Class II	Active
ProMIS™ Fixation System	87346	FDA UDI	Class II	Active
Hammering Sleeve	86250	FDA UDI	Class II	Active
ProMIS™ Fixation System	86794	FDA UDI	Class II	Active
Right Alignment Gauge Superior Crossbars Long	83106	FDA UDI	Class III	Active
Non-Cannulated Polyaxial Pedicle Screw	88508	FDA UDI	Class II	Active
Non-Cannulated Polyaxial Pedicle Screw	88513	FDA UDI	Class II	Active
ProMIS™ Fixation System	87492	FDA UDI	Class II	Active
Cannulated Tapered Pedicle Screw	88678	FDA UDI	Class II	Active
VersaLink™ Fixation System	87546	FDA UDI	Class II	Active
ProMIS™ Fixation System	87479	FDA UDI	Class II	Active
VersaLink™ Fixation System	82581	FDA UDI	Class II	Active
Rod Holding Forceps Self Retaining	86920	FDA UDI	Class II	Active
Cannulated Tapered Pedicle Screw	88679	FDA UDI	Class II	Active
ProMIS™ Fixation System	87664	FDA UDI	Class II	Active
Tap Ø 6.5 for Pendulum Adaptor	86640	FDA UDI	Class II	Active
Rod Inserter	86471	FDA UDI	Class II	Active
PER System 50	89012	FDA UDI	Class II	Active
MIS Reduction Torque Handle	86504	FDA UDI	Class II	Active
Non-Cannulated Polyaxial Pedicle Screw	88514	FDA UDI	Class II	Active
ProMIS™ Fixation System	86245	FDA UDI	Class II	Active
PER System 60	88989	FDA UDI	Class II	Active
Niti#1 Wire, Blunt Beveled Tip, L=470, Ø1.7mm Over K-Wire	87359	FDA UDI	Class III	Active
Cannulated Tapered Polyaxial Pedicle Screw	88672	FDA UDI	Class II	Active
Non-Cannulated Polyaxial Pedicle Screw	88515	FDA UDI	Class II	Active
VersaLink™ Fixation System	82562	FDA UDI	Class II	Active
ProMIS™ Fixation System	86242	FDA UDI	Class II	Active
VersaLink™ Fixation System	87554	FDA UDI	Class II	Active
Compressor	86600	FDA UDI	Class II	Active
Niti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm Over K-Wire	87009	FDA UDI	Class III	Active
Cannulated Tapered Pedicle Screw	88674	FDA UDI	Class II	Active
VersaLink™ Fixation System	87522	FDA UDI	Class II	Active
Ratchet T Handle	85837	FDA UDI	Class II	Active
VersaLink Nut Torque Wrench	83147	FDA UDI	Class II	Active
VersaLink™ Fixation System	87524	FDA UDI	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Premia Spine Ltd. Ramat Poleg, Netanya Central · IL FEI 3012401682