Progenix Plus

510(k) Number

K081950 ↗

FDA product code

NUN

Device class

Class II

Regulation

21 CFR Part 872.3930

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code NUN (Bone Grafting Material, Human Source).

• DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX by Musculoskeletal Transplant Foundation
• ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY by Isotis NV
• Intergro Oral by BIOMET 3I, LLC
• SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY by Hans Biomed Corp.
• REGENEROSS ALLOGRAFT PLUS MINERLIZED by Biomet Interpore Cross
• EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC by Exactech, Inc.
• GRAFTON PLUS DBM PASTE by Osteotech, Inc.
• GRAFTON DBM by Osteotech, Inc.
• ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY by Isotis NV
• DYNAGRAFT II DENTAL by ISOTIS ORTHOBIOLOGICS, INC

• MSB Reusable Instruments 9870005

  Class I

  GUDID on market

• MSB CD HORIZON Spinal System 6530530

  Class II

  FDA 510(k) K170679 Active Cleared 11 May 2017 GUDID on market

• T2 STRATOSPHERE™ Expandable Corpectomy System 436125C

  Class II

  FDA 510(k) K183510 Active Cleared 16 Jan 2019 GUDID on market

• MSB SHILLA Growth Guidance System 7670431

  Class II

  FDA 510(k) K140750 Active Cleared 17 Jul 2014 GUDID on market

See all devices from Medtronic Sofamor Danek, Inc. →