510(k) Report

FDA applicant

Creaspine

North Attleboro, MA3 decisions2007–20080 recalls

FDA records 3 decisions for Creaspine (North Attleboro, MA) from 2007 to 2008: 3 510(k) clearances. All are in product code MQP (Spinal Vertebral Body Replacement Device). Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Creaspine Sas”.

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 Creaspine’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Creaspine by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Creaspine’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?

  • MQPSpinal Vertebral Body Replacement Device3decisions

Whose devices does it build on?

Its devices cite 9 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.

  • K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas · 20071cites it

What has FDA decided for it lately?

  • K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine · 2008
  • K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine · 2008
  • K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas · 2007

All 2 as Creaspine →The one decision as Creaspine Sas →