---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-113506"
form_type: "8-K"
ticker: "TELA"
cik: "0001561921"
company_name: "TELA Bio, Inc."
filed_at: "2026-10-05T12:05:26+00:00"
generated_at: "2026-10-12T14:45:07.915557+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# TELA Bio wins FDA 510(k) clearance for Liora fully resorbable surgical mesh

## Summary
- FDA granted 510(k) clearance for Liora Monofilament Scaffold, a fully resorbable synthetic surgical mesh for soft tissue reinforcement.
- Liora is the first implant fully developed in TELA Bio's ISO 8 certified cleanroom in Malvern, PA, and the first fully resorbable synthetic product in its portfolio.
- CEO Heather Getz called the clearance 'a significant milestone' that expands options for surgeons and patients in soft tissue reconstruction.
- Company says Liora expands its footprint in the soft tissue reconstruction market; more details to come on the Q3 earnings call expected in early November.

## SEC filing metadata
- accession: 0001104659-26-113506
- form_type: 8-K
- ticker: TELA
- cik: 0001561921
- company_name: TELA Bio, Inc.
- filed_at: 2026-10-05T12:05:26+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1561921/000110465926113506/0001104659-26-113506-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1561921/000110465926113506/tm2627013d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-113506
- JSON: https://secwatch.observer/filing/0001104659-26-113506.json
- Plain text: https://secwatch.observer/filing/0001104659-26-113506.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.