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

Salt Lake City, UT, US

NEXUS SPINE, L.L.C. appears in FDA device records in Salt Lake City, UT. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
19
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 19 510(k) clearances for Nexus Spine, L.L.C. between 2014 and 2026. The busiest year on record is 2023, with 6. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nexus Spine, L.L.C., by decision year
YearClearances
20141
20161
20171
20183
20221
20236
20243
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261279DeltaNEC Interbody SystemOVESubstantially Equivalent
K253331PressON Spinal Fixation SystemNKBSubstantially Equivalent
K243934Stable-L Lumbar Interbody SystemOVDSubstantially Equivalent
K241467Stable-C Interbody SystemOVESubstantially Equivalent
K233375Tranquil-L Interbody SystemMAXSubstantially Equivalent
K240416Tranquil-C Interbody SystemODPSubstantially Equivalent
K233234PressON Spinal Fixation SystemNKBSubstantially Equivalent
K231486Stable-L Standalone Lumbar Interbody SystemOVDSubstantially Equivalent
K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVDSubstantially Equivalent
K231763Stable-C Interbody SystemOVESubstantially Equivalent
K223529PressON Spinal Fixation SystemNKBSubstantially Equivalent
K223627PreView-III™ Anterior Cervical Plate SystemKWQSubstantially Equivalent
K212498Stable-L Standalone Lumbar Interbody SystemOVDSubstantially Equivalent
K181621Stable-C Interbody SystemOVESubstantially Equivalent
K181702Tranquil-L Interbody SystemMAXSubstantially Equivalent
K181483Tranquil Interbody SystemMAXSubstantially Equivalent
K170297Tranquil Interbody SystemMAXSubstantially Equivalent
K160820PressON Pro Spinal Fixation SystemNKBSubstantially Equivalent
K133287PRESSON SPINAL FIXATION SYSTEMMNHSubstantially Equivalent

Registered establishments

FDA registered establishments for Nexus Spine, L.L.C., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30113907633011390763NEXUS SPINE, L.L.C.2825 E COTTONWOOD PKWY STE 330, Salt Lake City, UT 84121 US2026and 2 more, listed in full below
30182104893018210489NEXUS SPINE, LLC.4421 N Thanksgiving Way, Suite 101, Lehi, UT 84043 US2026and 2 more, listed in full below

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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