510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132596Substantially Equivalent

Proposed Optimus

Custom Spine, Inc., Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132596 is the FDA 510(k) clearance record for PROPOSED OPTIMUS, a class II device, cleared for Custom Spine, Inc. on under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar). FDA's definition for product code OVD reads: "Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation". FDA records list 14 510(k) clearances for Custom Spine, Inc., from to . As of , FDA records show one recall naming K132596.

Clearance record

Decision date
Received
(235 days to decision)
Product code
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Custom Spine, Inc. 9 Campus Dr., Parsippany NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVD

Trailing 12 months
9 clearances under product code OVD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OVD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260