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FDA 510(k)

MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM

K-Number: K021825 · 2002-07-01

ApplicantUnitedstates Surgical
Decision Date2002-07-01
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Unitedstates Surgical. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K021825. 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 MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM?

MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Unitedstates Surgical. The 510(k) number is K021825.

When did MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM received FDA 510(k) clearance on 2002-07-01, under 510(k) number K021825.

Who is the listed applicant for MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM?

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

What is the FDA product code for MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM?

The FDA product code for MODIFICATION TO SPIRAL RADIUS 90-D SST 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 Unitedstates Surgical 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.

K020352SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE

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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