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CranioSculpt C-FORM3CC

by Skeletal Kinetics LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Overview

CranioSculpt is a bioabsorbable bone matrix implant used for osteoconductive bone-tissue scaffolds, and sometimes osteovascularization to replace bone lost through trauma, surgery, or pathological conditions. It fills cystic defects, repairs fractures, and extends autogenous bone grafts.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813845020412 UDI-DI Date30 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CranioSculpt
Generic Name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
C-FORM3CC
Primary DI / UDI-DI
00813845020412
FDA Product Code
GXP
GMDN Term
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Device Class
Class II
Regulation Number
882.5300
GUDID distribution status
Not in Commercial Distribution
Size
Total Volume — 3 Milliliter

Other devices from Skeletal Kinetics LLC

See all devices from Skeletal Kinetics LLC →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No