Tornier Humeral Nail and Tornier Long Humeral Nail
FDA 510(k) K230352 · Tornier, Inc.
510(k) numberK230352
Submission
- Device name
- Tornier Humeral Nail and Tornier Long Humeral Nail
- Applicant
- Tornier, Inc.
Bloomington, MN, US - Received
- February 9, 2023
- Decision date
- October 31, 2023
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | 07/22/2026SE |
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| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | 09/14/2022SE |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient…PHX · Traditional | 11/12/2021SE |
| K213124 | Tomier Perform Reversed Glenoid Cannulated GlenospheresPHX · Special | 10/26/2021SE |
| K201315 | PERFORM Humeral System StemPAO · Traditional | 09/11/2020SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | 08/05/2020SE |
| K191711 | ORTHOLOC SPS Shoulder Plating SystemHRS · Special | 07/17/2019SE |
Questions and answers
When was Tornier Humeral Nail and Tornier Long Humeral Nail cleared by the FDA?
Tornier Humeral Nail and Tornier Long Humeral Nail (K230352) received a 510(k) decision of Substantially Equivalent on October 31, 2023, 264 days after the submission was received.
What is the product code of K230352?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.