restor3d TIDAL Lumbar Interbody Fusion System
Restor3D · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Durham
- Advisory committee description
- Orthopedic
- Address 1
- 4001 E. Nc 54 Hwy., Suite 3160
- Statement or summary
- Summary
- Product code
- MAX
- Zip code
- 27709
- Applicant
- Restor3D
- Decision date
- 2024-01-22
- Decision code
- SESE
- Country code
- US
- Device name
- restor3d TIDAL Lumbar Interbody Fusion System
- Advisory committee
- OR
- Contact
- Anika Moorjani
- K number
- K234087
- State
- NC
- Date received
- 2023-12-22
- Review advisory committee
- OR
- Postal code
- 27709
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3080
- Device class
- 2
- Registration number
- 9617297, 3007604895, 1226544, 8010273, 3007993775, 3007485169, 3008864603, 3006846753, 3016099068, 3010866843, 3017065977, 1000493591, 3009554293, 3005819474, 9615766, 3006563559, 3033739814, 3017780544, 3043543260, 3010375065, 3010370880, 3010646402, 2531477, 3013514648, 3036756245, 3013546462, 3010039400, 3016460869, 3011127597, 1828288, 1219655, 3011556898, 3015941638, 3005751028, 3024999441, 3009756327, 3016112537, 3009882462, 2133687, 3008526708 +393 more
- FEI number
- 3000718490, 3007604895, 3007993775, 1000139987, 1000069183, 3007485169, 3008864603, 3006846753, 3016099068, 1000143502, 3010866843, 3003690049, 3017065977, 1000493591, 3009554293, 3005819474, 3006563559, 3003112432, 3033739814, 3017780544, 3043543260, 3010375065, 3010370880, 3010646402, 3013514648, 3036756245, 3013546462, 3010039400, 3003142829, 3011127597, 1828288, 3016460869, 1219655, 3011556898, 3005751028, 3024999441, 3016112537, 3009882462, 3008526708, 1000514656 +393 more