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FDA 510(k)

ISSYS PEDICLE SCREW SYSTEM

K-Number: K043522 · 2005-01-14

ApplicantCustom Spine, Inc.
Decision Date2005-01-14
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISSYS PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Custom Spine, Inc.. It received FDA 510(k) clearance on 2005-01-14 under 510(k) number K043522. 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 ISSYS PEDICLE SCREW SYSTEM?

ISSYS PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2005-01-14. The listed applicant is Custom Spine, Inc.. The 510(k) number is K043522.

When did ISSYS PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

ISSYS PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2005-01-14, under 510(k) number K043522.

Who is the listed applicant for ISSYS PEDICLE SCREW SYSTEM?

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

What is the FDA product code for ISSYS PEDICLE SCREW SYSTEM?

The FDA product code for ISSYS PEDICLE SCREW 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 Custom Spine, 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.

K120597KOMPREDAK111726PATHWAY AVIDK111099ISSYS LP SPINAL FIXATION SYSTEMK092904PATHWAY IVB/VBRK091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATEK090566PATHWAY AVID

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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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