510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Premia Spine Ltd.

Ramat Poleg, Netanya Central, IL

PREMIA SPINE LTD. appears in FDA device records in Ramat Poleg, Netanya Central, IL. FDA records list 6 510(k) clearances between and , 11 PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
11
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 6 510(k) clearances for Premia Spine Ltd. between 2015 and 2023. The busiest year on record is 2023, with 2. The most recent is 2023, with 2.

Clearances by year, as a table
510(k) clearance decisions for Premia Spine Ltd., by decision year
YearClearances
20151
20171
20181
20191
20232
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232719ProMIS Extension Rod SystemNKBSubstantially Equivalent
K231844ProMIS™ Fixation SystemNKBSubstantially Equivalent
K191854Premia Spine XL InstrumentsOLOSubstantially Equivalent
K182598VersaLink™ Fixation SystemNKBSubstantially Equivalent
K170061ProMIS™ Fixation SystemNKBSubstantially Equivalent
K150380ProMIS Fixation SystemNKBSubstantially Equivalent

Registered establishments

FDA registered establishments for Premia Spine Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30124016823012401682PREMIA SPINE LTD.Giborey Israel 7, Ramat Poleg, Netanya Central 4250407 IL2026
30124529283012452928Premia Spine Inc11 Commerce St, Norwalk, CT 06850 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2516-2025TOPS 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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain