Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails
FDA 510(k) K083497 · Zimmer, Inc.
510(k) numberK083497
Submission
- Device name
- Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- November 25, 2008
- Decision date
- February 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
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| K261683 | Augment Off-Axis Instrument SystemPHX · Special | 06/16/2026SE |
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| 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 |
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Questions and answers
When was Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails cleared by the FDA?
Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (K083497) received a 510(k) decision of Substantially Equivalent on February 19, 2009, 86 days after the submission was received.
What is the product code of K083497?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.