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FDA 510(k)

LEA PLAZA SPINAL FRAME SYSTEM

K-Number: K884585 · 1989-01-27

ApplicantOrthomet, Inc.
Decision Date1989-01-27
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEA PLAZA SPINAL FRAME SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1989-01-27 under 510(k) number K884585. 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 LEA PLAZA SPINAL FRAME SYSTEM?

LEA PLAZA SPINAL FRAME SYSTEM is a medical device that received FDA 510(k) clearance on 1989-01-27. The listed applicant is Orthomet, Inc.. The 510(k) number is K884585.

When did LEA PLAZA SPINAL FRAME SYSTEM receive FDA 510(k) clearance?

LEA PLAZA SPINAL FRAME SYSTEM received FDA 510(k) clearance on 1989-01-27, under 510(k) number K884585.

Who is the listed applicant for LEA PLAZA SPINAL FRAME SYSTEM?

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

What is the FDA product code for LEA PLAZA SPINAL FRAME SYSTEM?

The FDA product code for LEA PLAZA SPINAL FRAME SYSTEM is KWP.

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Other records listing Orthomet, 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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