FDA.report

510(k) K212962

Device
TRELLIS? SI Joint Fusion System
Applicant
Orthofundamentals, LLC
510(k) number
K212962
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-11
Date received
2021-09-16
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Matthew Palmer
Address
173 Governors Ave. Medford MA US 02155 02155

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
G204OFSIANDG0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2025-05-07
G204OFSI16OF0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-12-11
G204OFSI20OF0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-12-11
G204OFSI24TP0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-12-11
G204OFSIINST0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-12-11
G204OFSIPLIN0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-12-11
G204OFSIREM0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-12-11
G204OFSISPLY0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-12-11
G204OFSI09700Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI11300Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09650Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09600Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09550Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09500Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09450Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09400Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09350Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI09300Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI11500Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI11700Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI1165FT0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI11650Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI1160FT0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI11600Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI1155FT0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI11550Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI1150FT0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI1170FT0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI1145FT0Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15
G204OFSI11450Trellis SI Joint Fusion SystemOrthofundamentals, LLC2024-07-15

Other 510(k) Records For Product Code OUR

510(k)DeviceApplicantDecision date
K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical2026-04-08
K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.2026-02-11
K253611Falco Fusion SystemMcnicoll Surgical, Inc.2026-01-29
K252834Sacroiliac Joint Truss System (SJTS)4Web Medical2026-01-28
K251365OptumSI Implant SystemSi Solutions, LLC2025-11-20
K252322SIros-X SystemGenesys Spine2025-10-22
K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.2025-10-09
K250894Eminent Spine Posterior SI SystemEminent Spine2025-10-07
K250647SImmetry+ SystemSivantage2025-07-29
K250247panaSIa SI Fusion SystemWenzel Spine, Inc.2025-07-09
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.2025-06-26
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC2025-06-06
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-06
K250001Patriot SI Implant SystemSpinal Simplicity, LLC2025-06-03
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC2025-04-25