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FDA 510(k)

BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM

K-Number: K103205 · 2011-06-02

ApplicantAlphatec Spine, Inc.
Decision Date2011-06-02
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM 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 2011-06-02 under 510(k) number K103205. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM?

BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K103205.

When did BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM receive FDA 510(k) clearance?

BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM received FDA 510(k) clearance on 2011-06-02, under 510(k) number K103205.

Who is the listed applicant for BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM?

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 BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM?

The FDA product code for BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM is KWP.

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Other records listing Alphatec Spine, Inc. as applicant

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K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemK253216IntraOp Alignment System; CONTOUR3D Bending SystemK253615Invictus Bands SystemK252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix SystemK251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

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Related Devices (Code: KWP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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