510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K152987Substantially Equivalent

Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System

Xenco Medical LLC, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K152987 is the FDA 510(k) clearance record for Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System, a class II device, cleared for Xenco Medical, LLC on under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical). FDA's definition for product code ODP reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list 16 510(k) clearances for Xenco Medical, LLC, from to . As of , FDA records show no recalls naming K152987.

Clearance record

Decision date
Received
(59 days to decision)
Product code
ODP Intervertebral Fusion Device With Bone Graft, Cervical
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Xenco Medical, LLC 9930 Mesa Rim Rd., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code ODP

Trailing 12 months
24 clearances under product code ODP in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code ODP, trailing twelve months
MonthClearances
November 20253
December 20252
January 20265
February 20261
March 20262
April 20264
May 20262
June 20260
July 20263
August 20262
September 20260
October 20260