Pegasus Biologics Orthadapt Surgical Mesh

FDA 510(k) K043388 · Pegasus Biologics, Inc.

Substantially Equivalent

510(k) numberK043388

Submission

Device name
Pegasus Biologics Orthadapt Surgical Mesh
Applicant
Pegasus Biologics, Inc.
Irvine, CA, US
Received
December 9, 2004
Decision date
August 5, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FTM – Mesh, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code FTM

510(k)DeviceApplicantDecision
K262406EluPro Antibiotic-Eluting BioEnvelopeFTM · Special Boston Scientific08/12/2026SE
K250598Endoform Reconstructive Template - PLGAFTM · Traditional Aroa Biosurgery , Ltd.06/03/2025SE
K243595OviTex PRS (Long-Term Resorbable)FTM · Special TELA Bio, Inc.12/19/2024SE
K233991CanGaroo RM Antibacterial EnvelopeFTM · Traditional Elutia, Inc.06/14/2024SE
K241126OviTex PRSFTM · Special TELA Bio, Inc.05/22/2024SE
K223052Peri-Guard and Supple Peri-GuardFTM · Traditional Synovis Life Technologies, Inc.04/07/2023SE
K214070OviTex PRS (Long Term Resorbable)FTM · Traditional Tela Bio03/21/2023SE
K213163VersaWrapFTM · Special Alafair Biosciences, Inc.10/29/2021SE
K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…FTM · Special Synovis Life Technologies. Inc. (A Subsidiary of…10/27/2021SE
K203496Nexo-Gide Bilayer Collagen MembraneFTM · Traditional Geistlich Pharma AG07/14/2021SE

More from Geistlich Pharma AG

510(k)DeviceDecision
K090288Orthadapt PRFTL · Traditional 05/05/2009SE
K071425Unite BiomatrixKGN · Special 06/20/2007SE
K071065Orthadapt BioimplantFTM · Special 05/04/2007SE
K061494Dermadapt Wound DressingKGN · Traditional 09/21/2006SE

Questions and answers

When was Pegasus Biologics Orthadapt Surgical Mesh cleared by the FDA?

Pegasus Biologics Orthadapt Surgical Mesh (K043388) received a 510(k) decision of Substantially Equivalent on August 5, 2005, 239 days after the submission was received.

What is the product code of K043388?

The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.