K231033
- 510(k) number
- K231033
- Device name
- CEPTRE® Knotted UHMWPE Suture PEEK Anchor
- Applicant
- Healthium Medtech Limited IN
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2024-01-04
- Date received
- 2023-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K231033.pdf
Official FDA record: K231033
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.