510(k) K113770 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
ORTHOFIX GALAXY FIXATION SYSTEM
| Applicant | Orthofix Srl, Oregon City OR, US |
| Decision | Substantially Equivalent, Sep 4, 2012 |
| Received | Dec 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix MINIRAIL, STANDARD LENGTHENER
Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | None listed |
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix MINIRAIL, SHORT, LENGTHENER
REF: M103, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | None listed |
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS
REF: M111, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | None listed |
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS
REF: M122, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502,
LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref:99-93503 ,
ANKLE STERILE KIT, UDI: (01)18033509859922 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93503US,
ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304 Terminated |
KTT | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93504,
ELBOW STERILE KIT, UDI: (01)18054242511533 Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.