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Title 21 → Chapter I → Subchapter H → Part 888 → Subpart D → §888.3045

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Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices

§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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