Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath (K230874)
Description
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath by Suzhou Endophix Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230874
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath (K230874) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM | Smith & Nephew Inc., Endoscopy Div. | 2010 |
| K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | Smith & Nephew Endoscopy, Inc. | 2009 |
Trace the full predicate network for K230874
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.