---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-035822"
form_type: "8-K"
ticker: "TELA"
cik: "0001561921"
company_name: "TELA Bio, Inc."
filed_at: "2023-03-23T23:59:59+00:00"
generated_at: "2026-06-17T18:15:37.049174+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# TELA Bio receives FDA 510(k) clearance for OviTex PRS Long-Term Resorbable

## Summary
- FDA granted 510(k) clearance on March 23, 2023 for OviTex PRS Long-Term Resorbable.
- Product reinforces soft tissue in plastic and reconstructive surgery where weakness exists.
- Complements existing OviTex PRS Permanent and Short-Term Resorbable configurations.
- Design features bi-directional stretch and a fully resorbable long-term polymer.
- CEO Antony Koblish states it expands clinical utility and demonstrates tunable design capabilities.

## SEC filing metadata
- accession: 0001104659-23-035822
- form_type: 8-K
- ticker: TELA
- cik: 0001561921
- company_name: TELA Bio, Inc.
- filed_at: 2023-03-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1561921/000110465923035822/0001104659-23-035822-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1561921/000110465923035822/tm239776d3_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-035822
- JSON: https://secwatch.observer/filing/0001104659-23-035822.json
- Plain text: https://secwatch.observer/filing/0001104659-23-035822.txt

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