TRUGRAFT BGS SYRINGE, MODEL 600-041— 510(k) K043172
Substantially EquivalentOsteobiologics, Inc.
FDA 510(k) clearance K043172 for TRUGRAFT BGS SYRINGE, MODEL 600-041, Substantially Equivalent on 2005-01-07. Applicant: Osteobiologics, Inc.. Device class: 2.
Clearance details
- Applicant
- Osteobiologics, Inc.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code FMF
view allMore clearances from Osteobiologics, Inc.
view all- K051656 — OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
- K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
- K040047 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
- K033707 — POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
- K032673 — IMMIX PLASTIFILM
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.