Wire
FDA 510(k) K841628 · Plastafil, Inc.
510(k) numberK841628
Submission
- Device name
- Wire
- Applicant
- Plastafil, Inc.
Mchenry, IL, US - Received
- April 19, 1984
- Decision date
- July 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXN – Applier, Cerclage
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K024022 | Osteo-Cable SleeveHXN · Special | Biomet, Inc. | 01/23/2003SE |
More from Biomet, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841621 | Back Radius CutterHTX · Traditional | 09/20/1984SE |
| K841620 | Front Radius CutterHTX · Traditional | 09/20/1984SE |
| K841629 | Drill BitHTW · Traditional | 08/27/1984SE |
| K841627 | MalletHWA · Traditional | 08/27/1984SE |
| K841626 | PunchHXG · Traditional | 08/27/1984SE |
| K841625 | HookGAD · Traditional | 08/27/1984SE |
| K841624 | ProbeHRX · Traditional | 08/27/1984SE |
| K841618 | Threading TubeFZX · Traditional | 08/27/1984SE |
| K841617 | Strover HookHCF · Traditional | 08/27/1984SE |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | 07/11/1984SE |
Questions and answers
When was Wire cleared by the FDA?
Wire (K841628) received a 510(k) decision of Substantially Equivalent on July 23, 1984, 95 days after the submission was received.
What is the product code of K841628?
The FDA product code is HXN – Applier, Cerclage, a Class I (low risk) device regulated under 21 CFR 888.4540.