Laminectomy Set — catalogue reference OP Kit-11.
| Reference / SKU | OP Kit-11 |
| Material | AISI 440 / 17-4 PH precipitation-hardened stainless steel |
| Sterilization | Steam autoclave to 134 °C · EtO compatible |
| Quality system | ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered |
Instrument sets are pre-assembled groupings of complementary instruments for specific surgical applications: basic surgery sets, dental kits, ophthalmic sets, ENT trays, orthopaedic open-procedure sets, gynecological exam kits, and specialty sets for trauma, paediatric, vascular, and cardiac surgery. The value of a set is the curation: each instrument complements the others, sized and angled for the intended procedure’s typical tissue handling, and the set fits a standard tray for sterilization and handling. Distributors and group purchasing organizations frequently specify private-label sets with co-branded trays and instrument etching. Fizza supplies complete instrument sets from 300 units per SKU, with custom configuration and OEM packaging available.
- Knee Surgery Set (OP Kit-10)
- Major Orthopedic Set (OP Kit-12)
- Foot & Ankle Set (OP Kit-09)
Manufacturing compliance is verified through ISO 13485:2016 certification (the international medical-device quality standard), CE marking under EU MDR 2017/745, and FDA establishment registration. Certificate copies and regulatory documentation are available on request for inclusion in hospital procurement files and EU technical documentation packages. Sterilization validation follows ISO 17665 for steam autoclave at 134 °C.
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