PMA P250028S001

Device: Synergy Disc
Applicant: Synergy Spine Solutions, Inc.
PMA number: P250028
Supplement: S001
Product code: MJO
Decision date: 2026-04-09
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250028

Current openFDA PMA Record#

Device: Synergy Disc
Applicant: Synergy Spine Solutions, Inc.
PMA number: P250028
Supplement: S001
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2026-04-09
Decision code: APPR
Date received: 2026-03-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250028