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FDA 510(k)

ISOBAR SEMI-RIGID DUAL DAMPENER

K-Number: K071261 · 2008-04-17

ApplicantScient'X
Decision Date2008-04-17
Product CodeNQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISOBAR SEMI-RIGID DUAL DAMPENER is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X. It received FDA 510(k) clearance on 2008-04-17 under 510(k) number K071261. The device is classified under product code NQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOBAR SEMI-RIGID DUAL DAMPENER?

ISOBAR SEMI-RIGID DUAL DAMPENER is a medical device that received FDA 510(k) clearance on 2008-04-17. The listed applicant is Scient'X. The 510(k) number is K071261.

When did ISOBAR SEMI-RIGID DUAL DAMPENER receive FDA 510(k) clearance?

ISOBAR SEMI-RIGID DUAL DAMPENER received FDA 510(k) clearance on 2008-04-17, under 510(k) number K071261.

Who is the listed applicant for ISOBAR SEMI-RIGID DUAL DAMPENER?

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

What is the FDA product code for ISOBAR SEMI-RIGID DUAL DAMPENER?

The FDA product code for ISOBAR SEMI-RIGID DUAL DAMPENER is NQP.

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Other records listing Scient'X 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.

K062912SCIENT'X SPINAL SYSTEMK052763STELLA CERVICAL PLATEK052367SCIENT'X CEMENT RESTRICTORK050348CO VERTEBRAL BODY REPLACEMENTK051063POLYAXIAL HEMISPHERICAL SPINAL SCREWSK043001MX POLYAXIAL PEDICLE SCREW

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Related Devices (Code: NQP)

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.

K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K101704ZIMMER DTO PIN PRESS INSTRUMENTZimmer Spine, Inc.K101083DSS STABILIZATION SYSTEMParadigm Spine, LLCK092234DYNESYS TOP-LOADING SPINAL SYSTEMZimmer Spine, 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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