Stalif TT
FDA 510(k) K051027 · Surgicraft , Ltd.
510(k) numberK051027
Submission
- Device name
- Stalif TT
- Applicant
- Surgicraft , Ltd.
Chicago, IL, US - Received
- April 22, 2005
- Decision date
- June 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
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|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K091207 | Surgicraft Lockdown Acromioclavicular (Ac) DeviceHTN · Traditional | 02/15/2011SE |
| K072370 | Surgicraft Surgical Mesh SystemFTL · Traditional | 07/24/2008SE |
| K080447 | Surgicraft Screw Fixation SystemMBI · Traditional | 06/13/2008SE |
| K073109 | Stalif TT Intervertebral Body Fusion SystemOVD · Abbreviated | 06/04/2008SE |
| K072415 | Stalif (TM) COVE · Abbreviated | 01/25/2008SE |
| K041617 | Stalif TTMQP · Traditional | 09/08/2004SE |
| K991662 | Titanium Hartshill SystemKWP · Traditional | 11/08/1999SE |
| K982719 | The Bone TieHTY · Traditional | 09/25/1998SE |
| K965221 | Ransford Cervical Fixation SystemKWP · Traditional | 08/07/1997SE |
Questions and answers
When was Stalif TT cleared by the FDA?
Stalif TT (K051027) received a 510(k) decision of Substantially Equivalent on June 29, 2005, 68 days after the submission was received.
What is the product code of K051027?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.