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FDA 510(k)

KIRSCHNER SPINAL PRODUCT SYSTEM

K-Number: K854524 · 1985-12-09

ApplicantKirschner Medical Corp.
Decision Date1985-12-09
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSCHNER SPINAL PRODUCT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kirschner Medical Corp.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K854524. 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 KIRSCHNER SPINAL PRODUCT SYSTEM?

KIRSCHNER SPINAL PRODUCT SYSTEM is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K854524.

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

KIRSCHNER SPINAL PRODUCT SYSTEM received FDA 510(k) clearance on 1985-12-09, under 510(k) number K854524.

Who is the listed applicant for KIRSCHNER SPINAL PRODUCT SYSTEM?

The FDA 510(k) record lists Kirschner Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIRSCHNER SPINAL PRODUCT SYSTEM?

The FDA product code for KIRSCHNER SPINAL PRODUCT SYSTEM is KWP.

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Other records listing Kirschner Medical Corp. 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.

K940537KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEMK936274KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEMK942891SUMMIT TOTAL HIP SYSTEMK941486INTEGRITY TOTAL HIP SYSTEM, NON-POROUSK933843LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATEDK935951KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM

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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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