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Aesculap Spine System Additional Components

by Aesculap, Inc.

510(k) K980121

Aesculap Spine System Additional Components is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K980121 on 10 Jun 1998, 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 · Traditional NumberK980121 Date10 Jun 1998ClearedStatusActive

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  • Withdrawn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
KWP
Device class
Class II
Regulation
21 CFR Part 888.3050
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).

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