SKaffold ReNu SKMA-FL10

Trade Name

SKaffold ReNu

Generic Name

Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial

Model / Ref / Catalog

SKMA-FL10

Primary DI / UDI-DI

00813845020856

FDA Product Code

MQV

GMDN Term

Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial

Device Class

Class II

Regulation Number

888.3045

GUDID distribution status

Not in Commercial Distribution

Size

Total Volume — 10 Milliliter

• OsteoVation Impact

  Class II

  FDA 510(k) K162864 Active Cleared 13 Jan 2017

• Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation

  Class II

  FDA 510(k) K100986 Active Cleared 20 Jul 2010

• Skaffold Cis

  Unclassified

  FDA 510(k) K111538 Active Cleared 25 Oct 2011

• Callos Impact and Inject Bone Void Filler

  Class II

  FDA 510(k) K051123 Active Cleared 3 Jun 2005

• Skaffold Nmx Bone Void Filler

  Class II

  FDA 510(k) K132211 Active Cleared 4 Aug 2014

• Callos Promodel Bone Void Filler, Skaffold Mp (Macro Porous) Bone Void Filler

  Class II

  FDA 510(k) K112383 Active Cleared 7 Feb 2012

See all devices from Skeletal Kinetics LLC →