ALTERA SPACER— 510(k) K140411

Clearance details

Applicant

Globus Medical, Inc.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2014-02-18

Decision date

2014-07-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Audubon, PA, US

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• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K254043 — TRIVANCE Hip Stem2026-08-04
• K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
• K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System2026-05-07
• K253401 — SCRIPT Implant System2026-04-29
• K261043 — AUTOBAHN Nailing System2026-04-24

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2850-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2851-2020 — ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2852-2020 — ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2853-2020 — ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2854-2020 — ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2855-2020 — ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2856-2020 — ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2857-2020 — ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2858-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2859-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2860-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2861-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2862-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2863-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2864-2020 — ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2865-2020 — ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2866-2020 — ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2867-2020 — ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2868-2020 — ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿Class II·Terminated·Globus Medical, Inc.·20200722
• Z-2869-2020 — ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿Class II·Terminated·Globus Medical, Inc.·20200722

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140411.