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

Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

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

OJB is the FDA product code for Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate, 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 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OJB
Device name
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
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
3
Ingested recalls
0

Clearances, product code OJB

By decision year
3 clearances under product code OJB with a decision year between 2005 and 2015, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OJB by decision year
YearClearances
20051
20081
20151

Applicants with the most clearances

Product code OJB
Applicants holding the most 510(k) clearances under product code OJB
ApplicantClearances
Inion Oy3

Companies listing this code with FDA

Companies whose registered establishments list this code