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FDA 510(k)

STALIF X

K-Number: K130461 · 2013-08-28

ApplicantCentinel Spine, Inc.
Decision Date2013-08-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STALIF X is the device name listed in this FDA 510(k) record. The listed applicant is Centinel Spine, Inc.. It received FDA 510(k) clearance on 2013-08-28 under 510(k) number K130461. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STALIF X?

STALIF X is a medical device that received FDA 510(k) clearance on 2013-08-28. The listed applicant is Centinel Spine, Inc.. The 510(k) number is K130461.

When did STALIF X receive FDA 510(k) clearance?

STALIF X received FDA 510(k) clearance on 2013-08-28, under 510(k) number K130461.

Who is the listed applicant for STALIF X?

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

What is the FDA product code for STALIF X?

The FDA product code for STALIF X is OVD.

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 Centinel 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.

K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLXK120819STALIF C

Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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