Kapp Spinal Button
FDA 510(k) K843368 · Kapp Surgical Instrument, Inc.
510(k) numberK843368
Submission
- Device name
- Kapp Spinal Button
- Applicant
- Kapp Surgical Instrument, Inc.
Mchenry, IL, US - Received
- August 28, 1984
- Decision date
- September 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253115 | Lars AcjHTN · Traditional | Movmedix S.A.S. | 06/10/2026SE |
| K252081 | SportLinc Syndesmosis DeviceHTN · Traditional | Lincotek Medical | 03/27/2026SE |
| K253727 | Syndesmosis TightRope PROHTN · Special | Arthrex, Inc. | 12/22/2025SE |
| K251643 | Synchfix EVTHTN · Traditional | Wright Medical Technology, Inc. (Stryker… | 10/29/2025SE |
| K251134 | RipCordHTN · Traditional | TriMed, Inc. | 07/11/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | Acumed, LLC | 01/23/2025SE |
| K242091 | Bolo Button SystemHTN · Traditional | Fusion Orthopedics | 12/23/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | Vilex, LLC | 11/27/2024SE |
| K242311 | EXPERT - Flexible Joint Fixation SystemHTN · Traditional | GM Dos Reis Industria e Comercio Ltda. | 11/01/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | Vilex, LLC | 08/01/2024SE |
More from Vilex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K200289 | Michler-Kapp Cardiovascular Vent CatheterDWF · Traditional | 01/28/2021SE |
| K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536NEU · Special | 11/09/2007SE |
| K050384 | Kapp Bari-Ring, Model KS-BR-2005NEU · Traditional | 01/13/2006SE |
| K050657 | Mondeal Contour Ho SystemHRS · Traditional | 08/08/2005SE |
| K050655 | Mondeal Radius Ho System, Model KS-MR-2005HRS · Traditional | 08/08/2005SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | 07/28/2004SE |
| K030237 | Kapp Custom Radial Head Elbow ImplantKWI · Traditional | 08/29/2003SE |
| K844177 | Cosgrove Mitral Valve RetractorGAD · Traditional | 11/08/1984SE |
Questions and answers
When was Kapp Spinal Button cleared by the FDA?
Kapp Spinal Button (K843368) received a 510(k) decision of Substantially Equivalent on September 12, 1984, 15 days after the submission was received.
What is the product code of K843368?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.