Device classification

Intervertebral Fusion Device With Bone Graft, Thoracic

Orthopedic · 21 CFR 888.3080

Class IIProduct code PHM
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
PHM
Review panel
OR
Medical specialty
OR
Device name
Intervertebral Fusion Device With Bone Graft, Thoracic
Medical specialty description
Orthopedic
Device class
2
Definition
Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Regulation number
888.3080
Implant flag
Y
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K180480, K160958, K150994
Registration number
1226544, 2532027, 3005706667, 3009887475, 3030412764, 3009050824, 3015216945, 3012428435, 3017528621, 3010057495, 3003761012, 9611813, 3043543260, 9611390, 2531477, 3009732568, 3016050940, 3004188066, 3012764194, 3006791286, 3010041499, 1056553, 2031966, 1828288, 3016112537, 3019878714, 3005076207, 3014967969, 1224360, 3009973336, 3010863450, 3013422236, 1935627, 2183946, 3009998573, 3010120326, 3014273501, 1000200989, 1526534, 3004142400 +44 more
FEI number
3005706667, 1000306303, 3009887475, 3030412764, 3009050824, 3015216945, 3012428435, 3017528621, 3010057495, 3003761012, 3043543260, 3009732568, 3016050940, 3004188066, 3012764194, 3009256700, 3006791286, 3008647423, 1828288, 3000215273, 3016112537, 3019878714, 3005076207, 3014967969, 3009973336, 3010863450, 3013422236, 3002806773, 1935627, 3009998573, 3010120326, 3002980729, 3003292403, 3014273501, 1000200989, 1526534, 3004142400, 3006639944, 3002806685, 2027467 +44 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.