PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
FDA 510(k) K230655 · Signature Orthopaedics Pty, Ltd.
510(k) numberK230655
Submission
- Device name
- PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
- Applicant
- Signature Orthopaedics Pty, Ltd.
Lane Cove West, AU - Received
- March 9, 2023
- Decision date
- May 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | 03/12/2026SE |
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| K251771 | Cambridge Partial KneeHSX · Traditional | 12/16/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | 08/07/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | 05/13/2025SE |
| K242477 | Shoulder Soft Tissue AnchorsMBI · Traditional | 05/12/2025SE |
| K243043 | Origin Cemented Hip StemLZO · Traditional | 05/02/2025SE |
| K243029 | Origin TT StemLZO · Traditional | 03/11/2025SE |
| K243162 | World LinerMEH · Special | 11/25/2024SE |
| K240683 | Rx Knee SystemJWH · Traditional | 09/11/2024SE |
Questions and answers
When was PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw cleared by the FDA?
PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw (K230655) received a 510(k) decision of Substantially Equivalent on May 3, 2023, 55 days after the submission was received.
What is the product code of K230655?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.