510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Xenco Medical LLC

San Diego, CA, US

XENCO MEDICAL LLC appears in FDA device records in San Diego, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. 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
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Xenco Medical LLC between 2014 and 2025. The busiest year on record is 2015, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Xenco Medical LLC, by decision year
YearClearances
20141
20154
20163
20171
20182
20192
20211
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243673Xenco Medical CancelleX Cervical Interbody SystemODPSubstantially Equivalent
K223059Xenco Medical InterAlign Cervical Interbody SystemOVESubstantially Equivalent
K213456Xenco Medical Multilevel CerviKitKWQSubstantially Equivalent
K191074Sorrento Bone Graft SubstituteMQVSubstantially Equivalent
K190364CancelleX Porous Titanium Lumbar Interbody DeviceMAXSubstantially Equivalent
K173933Sorrento Bioglass Bone Graft SubstituteMQVSubstantially Equivalent
K180373CancelleX Porous Titanium Lumbar Interbody DeviceMAXSubstantially Equivalent
K170611SETx Pedicle Screw SystemNKBSubstantially Equivalent
K160313Xenco Medical Cervical Interbody SystemOVESubstantially Equivalent
K161478Xenco Medical Posterior Cervical SystemNKGSubstantially Equivalent
K160986Xenco Medical Pedicle Screw SystemNKBSubstantially Equivalent
K152987Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody SystemODPSubstantially Equivalent
K152302Xenco Medical Cervical Interbody System (Argus)ODPSubstantially Equivalent
K151733Xenco Medical Pedicle Screw SystemNKBSubstantially Equivalent
K143158Xenco Medical Lumbar Interbody SystemMAXSubstantially Equivalent
K140786XENCO MEDICAL CERVICAL INTERBODY SYSTEMODPSubstantially Equivalent

Registered establishments

FDA registered establishments for Xenco Medical LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30111811543011181154XENCO MEDICAL LLC9930 Mesa Rim Road, San Diego, CA 92121 US2026and 4 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