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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR888.3045]
See Related Information on Resorbable calcium salt bone void filler device. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 888 -- ORTHOPEDIC DEVICES

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 888.1(e) of this chapter for the availability of this guidance.

[68 FR 32636, June 2, 2003]

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