SYNTHES XRL— 510(k) K103320

Clearance details

Applicant

Synthes Spine Co.Lp

Product code

Code MQP

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2010-11-12

Decision date

2011-10-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, US

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• K121852 — SYNTHES ZERO-P VARIABLE ANGLE (VA)2012-07-25
• K112459 — SYNTHES ZERO-P2011-12-12
• K112068 — SYNTHES ZERO-P VARIABLE ANGLE (VA)2011-11-07
• K081568 — ANTEGRA-T2008-09-02
• K080020 — ARCOFIX2008-05-23

Injury

372

Malfunction

519

Total

891

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-1681-2014 — Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).Class II·Terminated·Synthes, Inc.·20140408

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103320.