(346 days)
The Skellite™ Synthetic Resorbable Bone Void Filler is indicated only for bony voids on I he Skence - Bynthone reability of the bony structure. Skelite "" is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, be gently paokid into belly veats may be surgically created osseous defects or osseous spine, and pervisy. Theose coloring to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The product can be mixed with bone marrow.
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§ 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.