SPIN DOWN RAPIDFLAP— 510(k) K031034

Clearance details

Applicant

Walter Lorenz Surgical, Inc.

Product code

Code GXN

Device class

Class 2

Regulation

21 CFR 882.5330

Advisory panel

Neurology

Date received

2003-04-01

Decision date

2003-05-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Jacksonville, FL, US

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Injury

208

Total

208

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-0393-2019 — Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.Class II·Terminated·Zimmer Biomet, Inc.·20180822
• Z-0394-2019 — Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.Class II·Terminated·Zimmer Biomet, Inc.·20180822
• Z-0395-2019 — Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.Class II·Terminated·Zimmer Biomet, Inc.·20180822
• Z-0396-2019 — Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.Class II·Terminated·Zimmer Biomet, Inc.·20180822
• Z-0397-2019 — Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.Class II·Terminated·Zimmer Biomet, Inc.·20180822
• Z-0398-2019 — Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.Class II·Terminated·Zimmer Biomet, Inc.·20180822

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031034.