# Osteosymbionics, LLC

- Location (FDA's records): Cleveland, OH
- FDA decisions: 4 (2007–2014): 4 510(k) clearances
- Product codes: GXN (2), GXP (1), MNF (1)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 8 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Stryker Leibinger GmbH & Co KG: 1 (https://510kreport.com/company/stryker-leibinger)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Implantech Associates, Inc.: 1 (https://510kreport.com/company/implantech-associates)
- Porex Surgical Products Group: 1 (https://510kreport.com/company/porex-surgical-products-group)

## Firms that cite its devices most
- Longeviti Neuro Solutions, LLC: 2 (https://510kreport.com/company/longeviti-neuro-solutions)
- Oxford Performance Materials, Inc.: 2 (https://510kreport.com/company/oxford-performance-materials)
- Kelyniam Global, Inc.: 1 (https://510kreport.com/company/kelyniam-global)
- Vanduzen Dba Medcad: 1 (https://510kreport.com/company/vanduzen-dba-medcad)

## Its most-cited devices
- K072601: Osteosymbionics Patient Specific Cranial Implant (2007), cited by 6
- K133082: Osteosymbionics Patient-Specific Cranial Plate (2014), cited by 1
- K121102: Osteosymbionics Peek Cranial Implant (2012), cited by 1

## Recent decisions
- K133082: Osteosymbionics Patient-Specific Cranial Plate (May 20, 2014)
- K121102: Osteosymbionics Peek Cranial Implant (Aug 8, 2012)
- K111069: Osteosymbionics, ST Temporalis Implant (Sep 22, 2011)
- K072601: Osteosymbionics Patient Specific Cranial Implant (Dec 10, 2007)

Source page: https://510kreport.com/company/osteosymbionics