Macmed Paediatric Intramedullary Nail
FDA 510(k) K991877 · Innervision, Inc.
510(k) numberK991877
Submission
- Device name
- Macmed Paediatric Intramedullary Nail
- Applicant
- Innervision, Inc.
Memphis, TN, US - Received
- June 2, 1999
- Decision date
- August 6, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992345 | Christoudias Slim Tip Electrode InsertGEI · Traditional | 09/10/1999SE |
| K982428 | Christoudias Gauze Dissector (Laparoscopic Hand Instrument)HET · Traditional | 10/09/1998SE |
| K940731 | Innervision Inc. Cannula/Trocar,Multiple TypesGCJ · Traditional | 09/13/1994SE |
| K940750 | Innervision,Inc. Laparoscopic ElectrodesGEI · Traditional | 08/23/1994SE |
| K940718 | Innervision Inc. Laparoscopic Hand InstrumentsHET · Traditional | 07/22/1994SE |
Questions and answers
When was Macmed Paediatric Intramedullary Nail cleared by the FDA?
Macmed Paediatric Intramedullary Nail (K991877) received a 510(k) decision of Substantially Equivalent on August 6, 1999, 65 days after the submission was received.
What is the product code of K991877?
The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.