AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE— 510(k) K071983

Clearance details

Applicant

Aesculap Implant Systems, Inc.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2007-07-19

Decision date

2008-05-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Center Valley, PA, US

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• K153629 — ArcadiusXP C Spinal System2016-05-25
• K132421 — AESCULAP PEEK XP SPINAL IMPLANT SYSTEM2014-01-22
• K123939 — S4 SPINAL SYSTEM2013-03-12
• K123352 — S4 SPINAL SYSTEM2012-12-12
• K111122 — AESCULAP SIBD XP SPINAL SYSTEM2011-08-04

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-1806-2013 — ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.Class II·Terminated·Aesculap, Inc.·20130618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071983.