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Siconus SI Joint Fixation System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K162121

by Camber Spine Technologies

Identity

Trade Name
Siconus™ SI Joint Fixation System FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI
Device Name
Ø7mm Bone Screw, Cannulated, 50mm FDA UDI
Model / Reference
SCL-07-050 FDA UDI
Description
Ø7mm Bone Screw, Cannulated, 50mm FDA UDI

Identifiers

Primary DI / UDI-DI
B030SCL070500 FDA UDI
510(k) Number
K162121 FDA 510(k)FDA UDI
FDA Product Code
OUR FDA 510(k)FDA UDI
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 7 Millimeter FDA UDI
Length — 50 Millimeter FDA UDI

Siconus SI Joint Fixation System by Camber Spine Technologies — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Camber Spine Technologies

Sources (2)

  • FDA 510(k) K162121 24 fields · synced Jun 18, 2026
  • FDA UDI 60458704-d61b-4325-97db-7a5d0458474a 36 fields · synced May 27, 2026