OARClass I

Injector, Vertebroplasty (Does Not Contain Cement)

21 CFR 888.4200 / Orthopedic

OAR is the FDA product code for Injector, Vertebroplasty (Does Not Contain Cement), a class I device type, regulated under 21 CFR 888.4200. FDA's definition for this code reads: "Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma)". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2005-09-06, and 26 recalls.

Classification record

Product code: OAR
Device name: Injector, Vertebroplasty (Does Not Contain Cement)
FDA definition: Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Regulation: 21 CFR 888.4200
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: 26

Clearances, product code OAR

By decision year

1 clearance under product code OAR with a decision year between 2005 and 2005, 2005 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OAR by decision year
Year	Clearances
2005	1

Applicants with the most clearances

Product code OAR

Applicants holding the most 510(k) clearances under product code OAR
Applicant	Clearances
ArthroCare Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 63 companies shown, in name order