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FDA 510(k)

UNIVERSAL CLAMP SPINAL FIXATION SYSTEM

K-Number: K110348 · 2011-08-11

ApplicantZimmer Spine
Decision Date2011-08-11
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL CLAMP SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine. It received FDA 510(k) clearance on 2011-08-11 under 510(k) number K110348. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL CLAMP SPINAL FIXATION SYSTEM?

UNIVERSAL CLAMP SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-11. The listed applicant is Zimmer Spine. The 510(k) number is K110348.

When did UNIVERSAL CLAMP SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

UNIVERSAL CLAMP SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2011-08-11, under 510(k) number K110348.

Who is the listed applicant for UNIVERSAL CLAMP SPINAL FIXATION SYSTEM?

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

What is the FDA product code for UNIVERSAL CLAMP SPINAL FIXATION SYSTEM?

The FDA product code for UNIVERSAL CLAMP SPINAL FIXATION SYSTEM is OWI.

Related Clinical Trials

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Other records listing Zimmer Spine 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.

K123552INSTINCT JAVA SYSTEMK122592INSTINCT JAVA SYSTEMK113270INSTINCT JAVA SYSTEMK111301INSTINCT JAVA SYSTEM

Related Devices (Code: OWI)

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.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, 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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