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FDA 510(k)

WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM

K-Number: K870830 · 1987-05-04

ApplicantWarsaw Orthopedic, Inc.
Decision Date1987-05-04
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Warsaw Orthopedic, Inc.. It received FDA 510(k) clearance on 1987-05-04 under 510(k) number K870830. 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 WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM?

WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM is a medical device that received FDA 510(k) clearance on 1987-05-04. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K870830.

When did WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM receive FDA 510(k) clearance?

WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM received FDA 510(k) clearance on 1987-05-04, under 510(k) number K870830.

Who is the listed applicant for WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM?

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

What is the FDA product code for WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM?

The FDA product code for WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM is KWP.

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Other records listing Warsaw Orthopedic, 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.

K892877CRADLE, HOSPITAL BED CLOTHINGK883783TSRH SACRAL SPINAL SCREWK883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEK880211TSRH H/M HOOK HOLDERK880212TSRH H/M HOOK HOLDER W/ROD MOVERK880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

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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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