Surgical instruments & jaws
316L, 17-4PH H1025/H900, MP35N. Hardened jaws, scissor blades, articulation hardware. 0.0002″ class on cutting edges.
Industries · Medical Devices
Medical work demands traceability, biocompatibility, and surface-finish discipline that 90% of CNC shops don’t maintain. We machine surgical instrument components, implant-grade titanium hardware, endoscope & minimally-invasive parts, and pharmaceutical-process valve trim — with the documentation to support 510(k) and PMA submissions.
01 · Why medical is different
Medical-device customers care less about a single tight tolerance and more about repeatable, documented, traceable production. A 510(k) submission requires the quality system to show every step from raw stock to final inspection. A PMA submission goes deeper still.
Our ISO 9001 quality system, ProShop ERP/MES paperless travelers, and SensFlo machine monitoring give medical customers the audit trail and process-control evidence they need. We’re not registered to ISO 13485 ourselves, but we work routinely with customers whose registration depends on supplier discipline that meets 13485 requirements — and we deliver to that standard.
02 · Components we make
316L, 17-4PH H1025/H900, MP35N. Hardened jaws, scissor blades, articulation hardware. 0.0002″ class on cutting edges.
Ti-6Al-4V ELI, CP titanium, PEEK Optima LT1. Bone screws, fixation plates, intramedullary rods. ISO 13485 documentation chain.
Small-diameter precision components in 316L, beryllium copper, MP35N. Often Swiss-type produced for L:D >5:1 features.
Optical mounts, fluidic manifolds, valve trim. 316L, MIC-6, PEEK. Surface finish 8 µin Ra typical for cleanability.
Pumps, valve internals for CIP/SIP environments. 316L electropolished per ASTM B912.
Pick-and-place hardware, fluidic interfaces, sample-handling fixtures. 6061, 316L, PEEK.
03 · Materials we run for medical
ISO 13485-aware production, lot traceability, validation-ready documentation. Send drawings — we'll quote against the regulatory requirements your program needs.
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