Identifiers
- 510(k) Number
- K970549 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SN FDA 510(k)
Titanium Alloy Bone Screws are fixation bone screws designed for the stabilization of bone fractures. These devices are intended for use in long and small bone fracture fixation procedures.
This device is identified under FDA 510(k) number K970549 and is classified as a class 2 orthopedic medical device. It is manufactured by Aesculap, Inc. and has received FDA 510(k) clearance.
Frequently asked questions
What are Titanium Alloy Bone Screws used for?
These screws are indicated for the stabilization of bone fractures. They are specifically designed for use in surgical procedures involving both long and small bone fracture fixation.
What is the regulatory status of these bone screws?
These devices are classified as class 2 orthopedic medical devices and have received FDA 510(k) clearance under the number K970549.
Who is the manufacturer of these fixation screws?
These Titanium Alloy Bone Screws are manufactured by Aesculap, Inc., located in South San Francisco, California.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TITANIUM ALLOY BONE SCREWS (K970549) - FDA 510 (k), TITANIUM ALLOY BONE SCREWS (K970549) — FDA 510(k) | Innolitics, TITANIUM ALLOY BONE SCREWS 510(k) K940207 - FDA.report, Titanium Alloy Bone Screws 510 (k) K970549 - FDA.report, CASPAR TITANIUM ALLOY BONE SCREWS (K936269) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970549 | Class II | Active |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA 510(k) K970549 24 fields · synced Sep 25, 2026