510(k) Report

FDA applicant

Black Box Medical

Midland, TX3 decisions2018–20200 recalls

FDA records 3 decisions for Black Box Medical (Midland, TX) from 2018 to 2020: 3 510(k) clearances. All are in product code NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 61 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Black Box Medical, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Black Box Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 22020: 1
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Black Box Medical by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Black Box Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 44 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 61 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K181554Stowe Pedicle Screw SystemBlack Box Medical · 20181cites it

What has FDA decided for it lately?

  • K201751Pedicle Screw SystemBlack Box Medical, LLC · 2020
  • K182283FUSE Pedicle Screw SystemBlack Box Medical · 2018
  • K181554Stowe Pedicle Screw SystemBlack Box Medical · 2018

All 2 as Black Box Medical →The one decision as Black Box Medical, LLC →

Other applicant names beginning “Black”

FDA records each applicant name separately; these may or may not be the same firm.

Black & Decker (Tm) 11Black & Black Surgical, Inc. 4Black Diamond Video, Inc. 2