# NXM: Prosthesis, Eyelid Spacer/Graft, Biologic

- Device class: 2; regulation: 21 CFR 886.3130; FDA's rule: 510(k) exempt
- FDA decisions: 2
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2009: 1

## Most-cited predicates
- K053622: Surgisis Ocular Graft (2006), cited by 1
- K090078: Kerasys Bioengineered Lamellar Patch Graft (2009), cited by 1

Source page: https://510kreport.com/product-code/NXM
Data by year (CSV): https://510kreport.com/product-code/NXM.csv