# Orthogen, LLC

- Location (FDA's records): Springfield, NJ
- FDA decisions: 2 (2001–2011): 2 510(k) clearances
- Names in FDA's records: Orthogen, LLC (1); Orthogen Corp. (1)
- Product codes: LYC (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 3 (1 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
- Bio-Lok Intl., Inc.: 1 (https://510kreport.com/company/bio-lok-intl)

## Firms that cite its devices most
- Ace Surgical Supply Co., Inc.: 1 (https://510kreport.com/company/ace-surgical-supply)
- Bio-Lok Intl., Inc.: 1 (https://510kreport.com/company/bio-lok-intl)

## Its most-cited devices
- K011403: Surgiplaster Calcium Sulfate Hemihydrate (2001), cited by 3

## Recent decisions
- K102208: Nanogen (May 6, 2011)
- K011403: Surgiplaster Calcium Sulfate Hemihydrate (Sep 11, 2001)

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