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STALIF TT Intervertebral Body Fusion System

by Surgicraft, Ltd.

510(k) K073109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK073109 Date4 Jun 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OVD
FDA applicant
Surgicraft , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The STALIF TT Intervertebral Body Fusion System is a radiolucent vertebral body replacement device designed for intervertebral body fusion. It is intended for use in the thoracic (T9 to T12) and lumbar spine (L1 to L5) to restore biomechanical integrity when used in conjunction with cancellous bone screws.

The device is inserted into the intervertebral body space of the cervical or lumbosacral spine. It is supplied as a Class II device with special controls under FDA 510(k) clearance (K073109) and is intended for use with bone grafting material. The system is used in orthopedic spinal fusion procedures and is provided non-sterile, requiring sterilization prior to use.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the STALIF TT Intervertebral Body Fusion System used for?

    The STALIF TT Intervertebral Body Fusion System is designed for intervertebral body fusion in the thoracic (T9 to T12) and lumbar spine (L1 to L5) to restore biomechanical integrity when used with cancellous bone screws and bone grafting material.

  • How is the STALIF TT Intervertebral Body Fusion System supplied and prepared for use?

    The device is supplied non-sterile and requires sterilization prior to use, as it is intended for implantation in spinal fusion procedures and must be processed according to validated sterilization protocols before surgical implantation.

  • What spinal regions is the STALIF TT Intervertebral Body Fusion System intended to treat?

    The system is intended for use in the thoracic spine from T9 to T12 and the lumbar spine from L1 to L5, where it is inserted into the intervertebral body space to support fusion and restore structural stability.