510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Folsom Metal Products, Inc.

Pelham, AL, US

FOLSOM METAL PRODUCTS, INC. appears in FDA device records in Pelham, AL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
8
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Folsom Metal Products, Inc. in 2010.

Clearances by year, as a table
510(k) clearance decisions for Folsom Metal Products, Inc., by decision year
YearClearances
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K100205FRONTIER DEVICES NEURO SYSTEMGWOSubstantially Equivalent

Registered establishments

FDA registered establishments for Folsom Metal Products, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10655953006803588FOLSOM METAL PRODUCTS, INC.1449 Court Pl, PELHAM, AL 35124 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2581-2025Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, SterileLabeling includes shelf life that has not been validated.Class IIOpen, Classified
Z-2580-2025Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, SterileLabeling includes shelf life that has not been validated.Class IIOpen, Classified
Z-2579-2025Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, SterileLabeling includes shelf life that has not been validated.Class IIOpen, Classified
Z-2578-2025Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, SterileLabeling includes shelf life that has not been validated.Class IIOpen, Classified
Z-2577-2025Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, SterileLabeling includes shelf life that has not been validated.Class IIOpen, Classified
Z-2576-2025Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, SterileLabeling includes shelf life that has not been validated.Class IIOpen, Classified
Z-0651-2025Small 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 Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)Units were not intended for commercial distribution and inadvertently distributed.Class IIOpen, Classified
Z-0650-2025DKS 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 Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)Units were not intended for commercial distribution and inadvertently distributed.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain