21 CFR 888.3045

§ 888.3045 Resorbable calcium salt bone void filler device.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 888.3045, § 888.3045 Resorbable calcium salt bone void filler device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91065
Permanent ID: ys:prov:91065@1
SHA-256: d8560e91991c306f16507de3e816b8e599831404933643bceced70a1fc08e9b8

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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.