Zimmer Ortho Guidance Systems- Hip Instruments
FDA 510(k) K033223 · Zimmer, Inc.
510(k) numberK033223
Submission
- Device name
- Zimmer Ortho Guidance Systems- Hip Instruments
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- October 6, 2003
- Decision date
- February 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | 06/16/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | 06/16/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | 05/28/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | 04/27/2026SE |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | 04/13/2026SE |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | 03/12/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | 03/09/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | 02/04/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | 08/11/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | 07/18/2025SE |
Questions and answers
When was Zimmer Ortho Guidance Systems- Hip Instruments cleared by the FDA?
Zimmer Ortho Guidance Systems- Hip Instruments (K033223) received a 510(k) decision of Substantially Equivalent on February 18, 2004, 135 days after the submission was received.
What is the product code of K033223?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.