FORZA Ti Spacer System
FDA 510(k) K203576 · Orthofix, Inc.
510(k) numberK203576
Submission
- Device name
- FORZA Ti Spacer System
- Applicant
- Orthofix, Inc.
Lewisville, TX, US - Received
- December 7, 2020
- Decision date
- March 3, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K242270 | OrthoNext Platform SystemQIH · Traditional | 12/19/2024SE |
| K242861 | TrueLok ElevateKTT · Traditional | 12/03/2024SE |
| K233867 | Fitbone TrochantericHSB · Traditional | 06/18/2024SE |
| K240749 | PILLAR SA Ti Spacer System (82-XXX)MAX · Traditional | 05/28/2024SE |
| K232648 | RODEO Telescopic NailHSB · Traditional | 05/03/2024SE |
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Questions and answers
When was FORZA Ti Spacer System cleared by the FDA?
FORZA Ti Spacer System (K203576) received a 510(k) decision of Substantially Equivalent on March 3, 2021, 86 days after the submission was received.
What is the product code of K203576?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.