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FDA 510(k)

AMT SPINAL SYSTEM

K-Number: K002059 · 2000-11-13

ApplicantMicron Precision Engineering, Inc.
Decision Date2000-11-13
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMT SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micron Precision Engineering, Inc.. It received FDA 510(k) clearance on 2000-11-13 under 510(k) number K002059. 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 AMT SPINAL SYSTEM?

AMT SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-13. The listed applicant is Micron Precision Engineering, Inc.. The 510(k) number is K002059.

When did AMT SPINAL SYSTEM receive FDA 510(k) clearance?

AMT SPINAL SYSTEM received FDA 510(k) clearance on 2000-11-13, under 510(k) number K002059.

Who is the listed applicant for AMT SPINAL SYSTEM?

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

What is the FDA product code for AMT SPINAL SYSTEM?

The FDA product code for AMT SPINAL SYSTEM is KWP.

Related Clinical Trials

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.

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Other records listing Micron Precision Engineering, Inc. as applicant

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.

K022768AMT POLYAXIAL PEDICLE SCREW

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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