Synthes Spiral Blade for Humeral Nail (SBHN)
FDA 510(k) K992348 · Synthes (Usa)
510(k) numberK992348
Submission
- Device name
- Synthes Spiral Blade for Humeral Nail (SBHN)
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- July 14, 1999
- Decision date
- September 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDS – Nail, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | Smith & Nephew, Inc. | 06/12/2025SE |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 09/20/2024SE |
| K241804 | TRIGEN INTERTAN 10S Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 08/22/2024SE |
| K233150 | NET BRAND Osteosynthesis Nailing SystemJDS · Traditional | Narang Medical , Ltd. | 02/20/2024SE |
| K230761 | TRIGEN META-NAIL Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 06/14/2023SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | Synthes (USA) Products, LLC | 09/03/2020SE |
| K192003 | Auxein Nailing SystemJDS · Traditional | Auxein Medical Private Limited | 06/10/2020SE |
| K193533 | WIN Flexible Nail SystemJDS · Traditional | Biomet, Inc. | 02/20/2020SE |
| K141737 | Conventus PHS SystemJDS · Traditional | Conventus Orthopaedics, Inc. | 04/08/2015SE |
| K123948 | China Nails and AccessoriesJDS · Traditional | Smith & Nephew, Inc. | 03/14/2013SE |
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| 510(k) | Device | Decision |
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| K180821 | TruMatch Graft Cage - Long BoneHRS · Traditional | 12/21/2018SE |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT · Traditional | 11/10/2016SE |
| K152239 | Zero-P Natural Plate SystemKWQ · Traditional | 12/02/2015SE |
| K141527 | Depuy Synthes Variable Angle Locking Hand SystemHRS · Traditional | 03/30/2015SE |
| K131984 | Synthes Synsonic Ulna NailHSB · Traditional | 03/31/2014SE |
| K130146 | Synthes Synflate Vertevral Balloon SystemNDN · Traditional | 05/20/2013SE |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateHRS · Traditional | 07/06/2012SE |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | 06/19/2012SE |
| K120854 | Synthes Va LCP Ankle Trauma SystemHRS · Traditional | 06/18/2012SE |
| K120275 | Synthes Acis/Vertebral Spacer CRODP · Traditional | 05/25/2012SE |
Questions and answers
When was Synthes Spiral Blade for Humeral Nail (SBHN) cleared by the FDA?
Synthes Spiral Blade for Humeral Nail (SBHN) (K992348) received a 510(k) decision of Substantially Equivalent on September 23, 1999, 71 days after the submission was received.
What is the product code of K992348?
The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.