FDA.reportPublic FDA data

XENCO MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30111811543011181154XENCO MEDICAL LLC1N2026-01-019930 Mesa Rim Road San Diego CA US 92121

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B064HB1180002Sorrento Bioglass 2cc (25 x 20 x 4 mm) - HB-118-00028582021505sales@xencomedical.com
B064HB1180005Sorrento Bioglass 5cc (25 x 50 x 4 mm) - HB-118-00058582021505sales@xencomedical.com
B064HB1180010Sorrento Bioglass 10cc (100 x 20 x 5 mm) - HB-118-00108582021505sales@xencomedical.com
B064HB1180012Sorrento Bioglass 12cc (100 x 20 x 6 mm) - HB-118-00128582021505sales@xencomedical.com
B064HB1180020Sorrento Bioglass 20cc (100 x 25 x 8 mm) - HB-118-00208582021505sales@xencomedical.com
B064HB1180024Sorrento Bioglass 24cc (25 x 240 x 4 mm) - HB-118-00248582021505sales@xencomedical.com
B064XM113000515cc Trabeculex™ Bio-inspired Matrix 5cm x 2.5cm x .4cm (5cc) - XM-113-0005858-202-1505sarahdo@xencomedical.com
B064XM1130012112 Trabeculex™ Bio-inspired Matrix 10cm x 2cm x .6cm (12cc) - XM-113-0012858-202-1505sarahdo@xencomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1749802043722328K213456Xenco Medical Multilevel CerviKitKWQ2021-12-21
1749801682906102K180373CancelleX Porous Titanium Lumbar Interbody DeviceMAX2018-08-24
1749801680936936K173933Sorrento Bioglass Bone Graft SubstituteMQV2018-09-13
1749802071946610K170611SETx Pedicle Screw SystemNKB2017-05-25
1749801025828007K161478Xenco Medical Posterior Cervical SystemNKG2016-09-06
1749801444883362K160986Xenco Medical Pedicle Screw SystemNKB2016-05-04
1749801684287720K160313Xenco Medical Cervical Interbody SystemOVE2016-10-21
1749801388736381K152987Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody SystemODP2015-12-11
1749801447035740K152302Xenco Medical Cervical Interbody System (Argus)ODP2015-09-10
1749801131941499K151733Xenco Medical Pedicle Screw SystemNKB2015-09-04
1749801102293394K143158Xenco Medical Lumbar Interbody SystemMAX2015-03-20
1749801691475798K141429SORRENTO BONE GRAFT SUBSTITUTEMQV2015-02-23
1749801988442823K140786XENCO MEDICAL CERVICAL INTERBODY SYSTEMODP2014-09-03
1749801071419333
1749801296150850
1749801299841496
1749801977187038

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB32017-05-25
ODP32015-12-11
MQV22018-09-13
MAX22018-08-24
KWQ12021-12-21
OVE12016-10-21
NKG12016-09-06

GUDID#

200 records. Showing 1-40. Next