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Aesculap Spine System Evolution

by Aesculap, Inc.

510(k) K980484

Aesculap Spine System Evolution is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K980484 on 2 Oct 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 NumberK980484 Date2 Oct 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  • Withdrawn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
MNI
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MNI (Orthosis, Spinal Pedicle Fixation).

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