← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K913415 # AESCULAP TITANIUM BONE SCREWS (K913415) _Aesculap, Inc. · HWC · Oct 29, 1991 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K913415 ## Device Facts - **Applicant:** Aesculap, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Oct 29, 1991 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K913415](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K913415) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K913415