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STALIF C

by Surgicraft, Ltd.

510(k) K072415

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 NumberK072415 Date25 Jan 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  • Withdrawn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)

Full name
Stalif (Tm) C
510(k) Number
FDA Product Code
OVE
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, 19 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 device is an intervertebral body fusion device, as defined by regulation number 21 CFR 888.3080 and regulation name Intervertebral body fusion device. It is a spinal implant intended for use in vertebral fusion procedures.

It was cleared via the FDA 510(k) pathway under K072415, with a substantially equivalent decision and abbreviated clearance type. The device is supplied by Surgicraft, Ltd. and is classified under product code OVE with advisory committee designation OR (Orthopedic).

Other devices from Surgicraft, Ltd.

See all devices from Surgicraft, Ltd. →

Questions

AI-generated answers, 19 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 (TM) C device used for?

    The STALIF (TM) C is an intervertebral body fusion device intended for use in vertebral fusion procedures. It is a spinal implant designed to facilitate fusion between vertebrae.

  • How is the STALIF (TM) C device supplied?

    The device is supplied by Surgicraft, Ltd., which is located at 111 Hill Rd., Douglassville, PA 19518 in the United States.

  • What is the regulatory status of the STALIF (TM) C device?

    The STALIF (TM) C device was cleared via the FDA 510(k) pathway under K072415 with a substantially equivalent decision and abbreviated clearance type.

  • What is the product classification of the STALIF (TM) C device?

    The device is classified under product code OVE with an advisory committee designation of OR (Orthopedic), indicating it is categorized as an orthopedic device.