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FDA 510(k)

PASSMED SPINAL SYSTEM

K-Number: K032094 · 2003-11-14

ApplicantMedicrea
Decision Date2003-11-14
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASSMED SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea. It received FDA 510(k) clearance on 2003-11-14 under 510(k) number K032094. 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 PASSMED SPINAL SYSTEM?

PASSMED SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-14. The listed applicant is Medicrea. The 510(k) number is K032094.

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

PASSMED SPINAL SYSTEM received FDA 510(k) clearance on 2003-11-14, under 510(k) number K032094.

Who is the listed applicant for PASSMED SPINAL SYSTEM?

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

What is the FDA product code for PASSMED SPINAL SYSTEM?

The FDA product code for PASSMED SPINAL 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 Medicrea 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.

K100484IMPIX MANTA CERVICAL INTERBODY DEVICEK062136PASS 2 SPINAL SYSTEMK050490OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER

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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