FDA 510(k)

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

K-Nummer: K251965 · 2025-08-28

Entscheidungsdatum2025-08-28

ProduktcodeKWQ

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K251965. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K251965.

When did Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) receive FDA 510(k) clearance?

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) received FDA 510(k) clearance on 2025-08-28, under 510(k) number K251965.

Who is the listed applicant for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)?

The FDA product code for Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) is KWQ.

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Weitere Einträge mit Alphatec Spine, Inc. als Antragsteller

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Verwandte Geräte (Code: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Vorderes Halsplatten-SystemZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

Offizielle Quelle

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