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

Spinal Channeling Instrument, Vertebroplasty

21 CFR 888.4540 / Orthopedic
FDA source (opens on fda.gov)

OCJ is the FDA product code for Spinal Channeling Instrument, Vertebroplasty, a class I device type, regulated under 21 CFR 888.4540. FDA's definition for this code reads: "Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OCJ
Device name
Spinal Channeling Instrument, Vertebroplasty
FDA definition
Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
2

Clearances, product code OCJ

By decision year
1 clearance under product code OCJ with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OCJ by decision year
YearClearances
20071

Applicants with the most clearances

Product code OCJ
Applicants holding the most 510(k) clearances under product code OCJ
ApplicantClearances
Benvenue Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order