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

Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh

21 CFR 888.3060 / Orthopedic
FDA source (opens on fda.gov)

OJM is the FDA product code for Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh, a class II device type, regulated under 21 CFR 888.3060. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OJM
Device name
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
FDA definition
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.
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OJM.