Avs PL PEEK Spacers
FDA 510(k) K093704 · Stryker Corp.
510(k) numberK093704
Submission
- Device name
- Avs PL PEEK Spacers
- Applicant
- Stryker Corp.
Allendale, NJ, US - Received
- December 1, 2009
- Decision date
- December 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Avs PL PEEK Spacers cleared by the FDA?
Avs PL PEEK Spacers (K093704) received a 510(k) decision of Substantially Equivalent on December 23, 2009, 22 days after the submission was received.
What is the product code of K093704?
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.