Data / Medical devices / United States / Tela Bio, Inc.

Tela Bio, Inc.: FDA-registered device maker in Malvern, PA, United States, 9 510(k) clearances

Name: Tela Bio, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tela Bio, Inc. is registered with the FDA (registration 3010513348) in Malvern, PA, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 28, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010513348
Address: 1 Great Valley Pkwy Ste 24, Malvern, PA, United States, 19355
Owner or operator: TELA Bio (10048385)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: October 22, 2018
Registered through: 2027
Brand names listed: Liora Monofilament Scaffold, OviTex IHR Reinforced Tissue Matrix, OviTex LPR Reinforced Tissue Matrix, OviTex PRS, OviTex PRS (LTR), OviTex PRS (STR), OviTex PRS Permanent, OviTex Reinforced BioScaffold with Permanent Polymer (OviTex) and more

Devices it lists

Device	Product code	Class	Role	Source
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 28, 2026	K260474	Liora Monofilament Scaffold	FTL	Substantially Equivalent	TELA Bio, Inc.	accessdata.fda.gov
June 3, 2025	K250598	Endoform Reconstructive Template - PLGA	FTM	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
December 19, 2024	K243595	OviTex PRS (Long-Term Resorbable)	FTM	Substantially Equivalent	TELA Bio, Inc.	accessdata.fda.gov
May 22, 2024	K241126	OviTex PRS	FTM	Substantially Equivalent	TELA Bio, Inc.	accessdata.fda.gov
March 21, 2023	K214070	OviTex PRS (Long Term Resorbable)	FTM	Substantially Equivalent	Tela Bio	accessdata.fda.gov
April 11, 2019	K183398	Endoform Restella	FTM	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
December 4, 2018	K181935	Endoform Reconstructive Template - Non Absorbable	FTL	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
June 16, 2016	K153632	Endoform Reconstructive Template	FTL	Substantially Equivalent	Aroa Biosurgery Limited (Formerly Mesynthes Limited)	accessdata.fda.gov
March 15, 2016	K153633	Endoform Reconstructive Template	FTM	Substantially Equivalent	Aroa Biosurgery Limited (Formerly Mesynthes Limited)	accessdata.fda.gov

Compare with other makers

Updated September 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.