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Precice™ Max System and Precice™ Ankle Salvage System

by Nuvasive Specialized Orthopedics, Inc. 510(k)

Active United States

510(k) K261651

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK261651 Date18 Jun 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HSB
FDA applicant
NuVasive Specialized Orthopedics
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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