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Plastafil, Inc.

United StatesFDA applicant, unverified

Devices
13

What Plastafil, Inc. makes

Plastafil, Inc. manufactures surgical instruments including drill guides, mallets, back radius cutters, drill bits, probes, wires, Strover hooks, front radius cutters, punches, slotted soft-tissue instruments, threading tubes, and soft-tissue instruments.

The company's devices are listed in the FDA 510(k) registry and include Class I and Class II devices. Plastafil, Inc. is based in the US.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

Newest first, rows 1-13 of 13

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  • Drill Guide Ref K841619

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Mallet Ref K841627

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Back Radius Cutter Ref K841621

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Drill Bit Ref K841629

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Probe Ref K841624

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Wire Ref K841628

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Strover Hook Ref K841617

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Front Radius Cutter Ref K841620

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Punch Ref K841626

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Slotted Soft-Tissue Instrument Ref K841623

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Threading Tube Ref K841618

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Soft-Tissue Instrument Ref K841622

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hook Ref K841625

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-13 of 13

Frequently asked questions

How many devices does Plastafil, Inc. have in the registry?

The registry currently lists 13 devices for Plastafil, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Plastafil, Inc.'s devices?

Among its 13 most recently registered devices, Plastafil, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Plastafil, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Plastafil, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Plastafil, Inc. in the registry?

The most recently registered devices listed for Plastafil, Inc. include DRILL GUIDE, MALLET, BACK RADIUS CUTTER and DRILL BIT.

Generated automatically from registry data and not verified by a human reviewer.