[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3045]

[Page 496]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 888_ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart D_Prosthetic Devices
 
Sec. 888.3045  Resorbable calcium salt bone void filler device.

    (a) Identification. A resorbable calcium salt bone void filler 
device is a resorbable implant intended to fill bony voids or gaps of 
the extremities, spine, and pelvis that are caused by trauma or surgery 
and are not intrinsic to the stability of the bony structure.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; 
Guidance for Industry and FDA.'' See Sec. 888.1(e) of this chapter for 
the availability of this guidance.

[68 FR 32636, June 2, 2003]