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FDA 510(k)

ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM

K-Number: K072081 · 2007-10-24

ApplicantAlphatec Spine, Inc.
Decision Date2007-10-24
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZODIAC DYNAMO SEMI-RIGID SPINAL 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 2007-10-24 under 510(k) number K072081. 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 ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM?

ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-24. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K072081.

When did ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM receive FDA 510(k) clearance?

ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM received FDA 510(k) clearance on 2007-10-24, under 510(k) number K072081.

Who is the listed applicant for ZODIAC DYNAMO SEMI-RIGID SPINAL 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 ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM?

The FDA product code for ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM is KWP.

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Other records listing Alphatec Spine, Inc. as applicant

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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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