PMA P220031

Device: LimiFlex™ Dynamic Sagittal Tether
Applicant: Empirical Spine, Inc.
PMA number: P220031
Supplement: S001
Product code: SGK
Decision date: 2026-04-08
Classification: Orthopedic
Generic name: Prosthesis, spinous process tension band implant
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 P220031

Current openFDA PMA Record#

Device: LimiFlex™ Dynamic Sagittal Tether
Applicant: Empirical Spine, Inc.
PMA number: P220031
Supplement: S001
Product code: SGK
Generic name: Prosthesis, spinous process tension band implant
Decision date: 2026-04-08
Decision code: APPR
Date received: 2026-03-12
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 P220031