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

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

21 CFR 888.3045 / Orthopedic
FDA source (opens on fda.gov)

OIS is the FDA product code for Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation, a class II device type, regulated under 21 CFR 888.3045. FDA's definition for this code reads: "To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
OIS
Device name
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
FDA definition
To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.
Regulation
21 CFR 888.3045
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
1
Ingested recalls
1

Clearances, product code OIS

By decision year
1 clearance under product code OIS with a decision year between 2008 and 2008, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OIS by decision year
YearClearances
20081

Applicants with the most clearances

Product code OIS
Applicants holding the most 510(k) clearances under product code OIS
ApplicantClearances
Synthes (USA) Products LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order