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FDA 510(k)

STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM

K-Number: K073109 · 2008-06-04

ApplicantSurgicraft , Ltd.
Decision Date2008-06-04
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgicraft , Ltd.. It received FDA 510(k) clearance on 2008-06-04 under 510(k) number K073109. 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 TT INTERVERTEBRAL BODY FUSION SYSTEM?

STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-04. The listed applicant is Surgicraft , Ltd.. The 510(k) number is K073109.

When did STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM receive FDA 510(k) clearance?

STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM received FDA 510(k) clearance on 2008-06-04, under 510(k) number K073109.

Who is the listed applicant for STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM?

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

What is the FDA product code for STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM?

The FDA product code for STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM is OVD.

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Other records listing Surgicraft , Ltd. 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.

K091207SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICEK072370SURGICRAFT SURGICAL MESH SYSTEMK080447SURGICRAFT SCREW FIXATION SYSTEMK072415STALIF (TM) CK051027STALIF TTK041617STALIF TT

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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

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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