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Modification to S4 Spinal System

by Aesculap, Inc. 2 variants

510(k) K060152

Modification to S4 Spinal System is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K060152 on 3 Feb 2006, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060152 Date3 Feb 2006ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MNI
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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