Independence Spacer
FDA 510(k) K120101 · Globus Medical, Inc.
510(k) numberK120101
Submission
- Device name
- Independence Spacer
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- January 12, 2012
- Decision date
- March 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
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Questions and answers
When was Independence Spacer cleared by the FDA?
Independence Spacer (K120101) received a 510(k) decision of Substantially Equivalent on March 27, 2012, 75 days after the submission was received.
What is the product code of K120101?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.