Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010513348

FEI Number

3010513348

Entity Name

TELA BIO, INC.

City/State/Country

Malvern, PA, US

Establishment Address

1 GREAT VALLEY PKWY STE 24, Malvern, PA 19355, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TELA Bio (Owner Number: 10048385)

Owner / Operator Contact Address

1 Great Valley Parkway, Suite 24, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243595

PMA Number

N/A

All Registered Proprietary Names

OviTex PRS (STR) OviTex PRS Permanent OviTex Reinforced Tissue Matrix Shaped Cutting Template OviTex LPR Reinforced Tissue Matrix OviTex Reinforced Tissue Matrix with Permanent Polymer (OviTex) OviTex IHR Reinforced Tissue Matrix OviTex Reinforced Tissue Matrix OviTex PRS (LTR)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2024-05-31
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-05-31
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-10-13
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-10-22
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2018-10-22
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2025-11-21
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-11-21
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2025-02-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TELA Bio

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010513348. Last updated year: 2026. Please use registration number 3010513348 when referencing this establishment in official correspondence.