ClearanceBrief
Company ยท US

Folsom Metal Products, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2010. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GCZRetainer, Surgical6
HAERongeur, Manual2
GWOPlate, Cranioplasty, Preformed, Alterable1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 13, 2010K100205FRONTIER DEVICES NEURO SYSTEM
Folsom Metal Products, Inc.
GWO

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 17, 2025Folsom Metal Products, Inc.
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Open, Classified
GCZNone listed
Sep 17, 2025Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Open, Classified
GCZNone listed
Sep 17, 2025Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Open, Classified
GCZNone listed
Sep 17, 2025Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Open, Classified
GCZNone listed
Sep 17, 2025Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Open, Classified
GCZNone listed
Sep 17, 2025Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Open, Classified
GCZNone listed
Dec 6, 2024Folsom Metal Products, Inc.
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small
Open, Classified
HAENone listed
Dec 6, 2024Folsom Metal Products, Inc.
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Light
Open, Classified
HAENone listed
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