Modification to Slim Gliding Nail System
FDA 510(k) K033763 · Plus Orthopedics
510(k) numberK033763
Submission
- Device name
- Modification to Slim Gliding Nail System
- Applicant
- Plus Orthopedics
San Diego, CA, US - Received
- December 2, 2003
- Decision date
- December 18, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
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| K070928 | Ceramic Ball Heads, 28, 32 and 36 MMLZO · Traditional | 08/01/2007SE |
| K070731 | Pigalileo Total Hip Replacement (THR) SystemHAW · Traditional | 07/31/2007SE |
| K070278 | Polarcup Dual Mobility SystemLPH · Traditional | 04/16/2007SE |
| K063578 | Promos Modular Shoulder SystemHSD · Traditional | 03/02/2007SE |
| K061362 | Pigalileo Total Knee Replacement (TKR) SystemHAW · Traditional | 10/06/2006SE |
| K032126 | Promos ShoulderHSD · Traditional | 01/08/2004SE |
| K032709 | Modular Plus Hip StemLWJ · Special | 09/23/2003SE |
| K032548 | Ip-Xs Compression Nail SystemHSB · Traditional | 09/10/2003SE |
| K032215 | Vks/Tc-Plus Revision KneeJWH · Special | 08/08/2003SE |
| K032052 | Uc-Plus Solution Unicondylar KneeHRY · Special | 07/25/2003SE |
Questions and answers
When was Modification to Slim Gliding Nail System cleared by the FDA?
Modification to Slim Gliding Nail System (K033763) received a 510(k) decision of Substantially Equivalent on December 18, 2003, 16 days after the submission was received.
What is the product code of K033763?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.