Synergy Disc
Synergy Spine Solutions, Inc. · Prosthesis, intervertebral disc · Orthopedic
Open FDA's page for this record- PMA number
- P250028
- Supplement number
- S003
- Applicant
- Synergy Spine Solutions, Inc.
- Street 1
- 357 S. Mccaslin Blvd., Suite 120
- City
- Louisville
- State
- CO
- Zip
- 80027
- Generic name
- Prosthesis, intervertebral disc
- Trade name
- Synergy Disc
- Product code
- MJO
- Advisory committee
- OR
- Advisory committee description
- Orthopedic
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-06-25
- Decision date
- 2026-09-17
- Decision code
- APPR
- Ao statement
- packaging materials changes and the addition of a secondary packaging configuration
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Intervertebral Disc
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 1835251, 3014213973, 1834331, 3014252644, 2029275, 3010057495, 3012447612, 3005061536, 3004774118, 1030489, 3037407500, 3010120326, 1833920, 3007494564, 3009144915, 1319660, 3006128100, 2531195, 2032098, 3003935342, 2031966, 3013491327, 2133928, 3016438694, 1424434, 1828464, 3011277306, 9610612, 3013944123, 3010363503, 3006001176, 3009417901, 1649518, 3024999441, 8044172, 3007017524, 1530390, 2183449, 3003120897, 3030714745 +38 more
- FEI number
- 3002980729, 3002806315, 3014213973, 3014252644, 3010057495, 3012447612, 3005061536, 3037407500, 3010120326, 3007494564, 3009144915, 3006128100, 3003935342, 3001236277, 3002287318, 3013491327, 3016438694, 1000477302, 3003110073, 1000115656, 1828464, 3011277306, 3013944123, 3000215273, 3010363503, 3006001176, 3008599177, 3009417901, 3024999441, 3007017524, 2183449, 3003120897, 3030714745, 2219920, 3008812560, 3004142400, 1000200989, 3010120339, 3010041430, 3003058448 +38 more