Tela Bio

FDA Filings

This page includes the latest FDA filings for Tela Bio. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010513348
• FEI Number: 3010513348
• Name: TELA BIO, INC.
• Owner & Operator: TELA Bio
• Contact Address: 1 Great Valley Parkway, Suite 24 ; Malvern PA 19355 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1 GREAT VALLEY PKWY STE 24 ; Malvern, PA 19355 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K183398 | FTM TELA BIO, INC. [TELA Bio]	OviTex PRS	2019-05-02
PMN K183398 | FTL TELA BIO, INC. [TELA Bio]	OviTex PRS	2019-05-02
PMN K181935 | FTM TELA BIO, INC. [TELA Bio]	OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)	2018-12-20
PMN K181935 | FTL TELA BIO, INC. [TELA Bio]	OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)	2018-12-20
PMN K153633 | FTM TELA BIO, INC. [TELA Bio]	OviTex Reinforced BioScaffold with Resorbable Polymer (OviTex)	2018-10-22
PMN K153632 | FTM TELA BIO, INC. [TELA Bio]	OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)	2018-10-22
PMN K153632 | FTM TELA BIO, INC. [TELA Bio]	OviTex LPR Reinforced BioScaffold	2018-10-22
PMN K153632 | FTL TELA BIO, INC. [TELA Bio]	OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)	2018-10-22
PMN K153632 | FTL TELA BIO, INC. [TELA Bio]	OviTex LPR Reinforced BioScaffold	2018-10-22

Similar & Related FDA Registered Companies

• TELA BIO, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018063044302	London,United Kingdom -> New York, New York	TAJIMA EMBROIDERY MACHINES WITH MAILING MATERIALS	9 PKG