Zavation Medical Products, LLC FDA Record
Zavation Medical Products, LLC has 0 FDA recalls, 0 inspections, 31 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Zavation Medical Products, LLC" is on file.
- Latest 510(k)
- Jul 24, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 31 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K253943 | Tiger 2 System | Jul 24, 2026 |
| K243908 | Tiger 2 System | Feb 3, 2025 |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System… | Apr 10, 2024 |
| K231811 | Zavation Connector System | Aug 22, 2023 |
| K223808 | Zavation Navigation Instrument System | Jul 12, 2023 |
| K230731 | Zavation ALIF System | Jun 14, 2023 |
| K221726 | Uni-FuZe-C Bone Strip | Jan 18, 2023 |
| K222614 | Zavation Spinal System | Dec 5, 2022 |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | Aug 12, 2022 |
| K220581 | Zavation eZspand Interbody System | Jun 2, 2022 |
| K212811 | Ti3Z Lumbar Interbody System | Apr 12, 2022 |
| K211993 | Z-LINKPC System | Aug 11, 2021 |
| K211113 | Zavation Spinal System | Jul 12, 2021 |
| K211306 | LABYRINTH | Jun 24, 2021 |
| K202398 | Ti3Z Cervical Interbody System | Jan 29, 2021 |
| K201781 | Uni-FuZe-P Bone Putty | Dec 28, 2020 |
| K202624 | Z-Span Plate System | Nov 4, 2020 |
| K200084 | Zavation IBF System | Oct 19, 2020 |
| K202305 | Zavation IBF System | Oct 13, 2020 |
| K191354 | Ti3Z Cervical Interbody System | Sep 9, 2019 |
Zavation Medical Products, LLC and the FDA: common questions
Has Zavation Medical Products, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Zavation Medical Products, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Zavation Medical Products, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Zavation Medical Products, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
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