{"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","discovered_at":"2026-05-14T18:03:45.585211+00:00","generated_at":"2026-06-17T18:15:37.049174+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"TELA Bio receives FDA 510(k) clearance for OviTex PRS Long-Term Resorbable","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-035822","json":"https://secwatch.observer/filing/0001104659-23-035822.json","markdown":"https://secwatch.observer/filing/0001104659-23-035822.md","text":"https://secwatch.observer/filing/0001104659-23-035822.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T18:15:37.049174+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}