Progenix Dbm Putty and Paste

510(k) Number

K060794 ↗

FDA product code

MBP

FDA applicant

Medtronic Sofamor Danek

Device class

Class II

Regulation

21 CFR Part 888.3045

Advisory committee

Orthopedic

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 MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)).

• OSTEOSET DBM PELLETS by Wrightmedicaltechnologyinc
• OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY by Bacterin International, Inc.
• GRAFTON PLUS DBM PASTE by Osteotech, Inc.
• VIVORTE BVF by Vivorte, Inc
• CAP PLUS, EQUIVABONE, CAP/DBM by Etex Corp.
• GRAFTON DBM by Osteotech, Inc.
• DBX Strip by Musculoskeletal Transplant Foundation
• AFT Allograft Filler Tube by Musculoskeletal Transplant Foundation
• PliaFX Flo by LIFENET HEALTH
• Vivorte Trabexus EB by Vivorte, 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. →