NOVOS-NAIL Limb Lengthening System (LLS)
FDA 510(k) K163653 · Smith & Nephew
510(k) numberK163653
Submission
- Device name
- NOVOS-NAIL Limb Lengthening System (LLS)
- Applicant
- Smith & Nephew
Memphis, TN, US - Received
- December 23, 2016
- Decision date
- October 13, 2017
- 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 |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
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| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
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Questions and answers
When was NOVOS-NAIL Limb Lengthening System (LLS) cleared by the FDA?
NOVOS-NAIL Limb Lengthening System (LLS) (K163653) received a 510(k) decision of Substantially Equivalent on October 13, 2017, 294 days after the submission was received.
What is the product code of K163653?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.