FDA product code · Orthopedic

Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh

Name: FDA decisions, review times, recalls and adverse event reports for product code OJM
Creator: 510(k) Report

OJMClass II21 CFR 888.3060510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of OJM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — OJM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OJM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 888.3060.

MQP Spinal Vertebral Body Replacement Device PHQ Anterior Staple As Supplemental Fixation For…JDN Implant, Fixation Device, Spinal OJB Resorbable Spinal Intervertebral Body Fixation…PLR Spinal Vertebral Body Replacement Device -…KWQ Appliance, Fixation, Spinal Intervertebral Body