Tezo Titanium Cage Family
FDA 510(k) K122957 · Ulrich GmbH & Co. KG
510(k) numberK122957
Submission
- Device name
- Tezo Titanium Cage Family
- Applicant
- Ulrich GmbH & Co. KG
Chesterfield, MO, US - Received
- September 25, 2012
- Decision date
- June 21, 2013
- 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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Questions and answers
When was Tezo Titanium Cage Family cleared by the FDA?
Tezo Titanium Cage Family (K122957) received a 510(k) decision of Substantially Equivalent on June 21, 2013, 269 days after the submission was received.
What is the product code of K122957?
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.