Data / Medical devices / Israel / Premia Spine Ltd.

Premia Spine Ltd.: FDA-registered device maker in Ramat Poleg, Netanya Central, Israel, 6 510(k) clearances and 1 PMA approval

Name: Premia Spine Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Premia Spine Ltd. is registered with the FDA (registration 3012401682) in Ramat Poleg, Netanya Central, Israel. It lists 5 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated November 21, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012401682
Address: Giborey Israel 7, Ramat Poleg, Netanya Central, Israel, 4250407
Owner or operator: Premia Spine Ltd. (10050301)
Roles: Manufacturer
First device listed: November 2, 2015
Registered through: 2027
Brand names listed: Premia Spine XL Instruments, ProMIS Extension Rod System, ProMIS Fixation System, TOPS System, VersaLink Fixation System

Devices it lists

Device	Product code	Class	Role	Source
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Posterior Spinal Elements	QWK	3	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 21, 2023	K232719	ProMIS Extension Rod System	NKB	Substantially Equivalent	Premia Spine, Ltd.	accessdata.fda.gov
July 7, 2023	K231844	ProMIS Fixation System	NKB	Substantially Equivalent	Premia Spine, Ltd.	accessdata.fda.gov
October 8, 2019	K191854	Premia Spine XL Instruments	OLO	Substantially Equivalent	Premia Spine, Ltd.	accessdata.fda.gov
November 13, 2018	K182598	VersaLink Fixation System	NKB	Substantially Equivalent	Premia Spine, Ltd.	accessdata.fda.gov
February 2, 2017	K170061	ProMIS Fixation System	NKB	Substantially Equivalent	Premia Spine, Ltd.	accessdata.fda.gov
July 17, 2015	K150380	ProMIS Fixation System	NKB	Substantially Equivalent	Premia Spine, Ltd.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 15, 2023	P220002	TOPS System	QWK	11	September 9, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 16, 2025	97367	Class II	Ongoing	TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.	Potential for missing pins at tip of inserter.	accessdata.fda.gov

Compare with other makers

Updated September 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.