# Black Box Medical

- Location (FDA's records): Midland, TX
- FDA decisions: 3 (2018–2020): 3 510(k) clearances
- Names in FDA's records: Black Box Medical (2); Black Box Medical, LLC (1)
- Product codes: NKB (3)
- 510(k) review time since 2016: median 44 days, against 61 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (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
- Acme Spine, LLC: 2 (https://510kreport.com/company/acme-spine)

## Its most-cited devices
- K181554: Stowe Pedicle Screw System (2018), cited by 1

## Recent decisions
- K201751: Pedicle Screw System (Jul 22, 2020)
- K182283: FUSE Pedicle Screw System (Oct 23, 2018)
- K181554: Stowe Pedicle Screw System (Jul 27, 2018)

Source page: https://510kreport.com/company/black-box-medical