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Altera Spacer

by Globus Medical, Inc.

510(k) K140411

Altera Spacer is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K140411 on 1 Jul 2014, active as of 22 Oct 2026. 22 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

22 closed

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 NumberK140411 Date1 Jul 2014ClearedStatusActive

Official records

Recalls

22 recalls · FDA

  • 22 recalls, same reason

    • Terminated Z-2870-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2852-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2866-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2863-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2854-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2855-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2859-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2862-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2860-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2851-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2857-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2861-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2869-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2871-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2865-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2867-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2850-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2856-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2858-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2864-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2868-2020 FDA Class II initiated 22 Jul 2020
    • Terminated Z-2853-2020 FDA Class II initiated 22 Jul 2020

    Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Timeline

23 dated events

  1. Recall initiated FDA recalls Z-2869-2020
  2. Recall initiated FDA recalls Z-2871-2020
  3. Recall initiated FDA recalls Z-2865-2020
  4. Recall initiated FDA recalls Z-2867-2020
  5. Recall initiated FDA recalls Z-2850-2020
  6. Recall initiated FDA recalls Z-2856-2020
  7. Recall initiated FDA recalls Z-2858-2020
  8. Recall initiated FDA recalls Z-2864-2020
  9. Recall initiated FDA recalls Z-2868-2020
  10. Recall initiated FDA recalls Z-2853-2020

13 earlier events are in the sections above.

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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

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