Zeta Multizone Locking Nail System
FDA 510(k) K984305 · Howmedica, Inc.
510(k) numberK984305
Submission
- Device name
- Zeta Multizone Locking Nail System
- Applicant
- Howmedica, Inc.
Rutherford, NJ, US - Received
- December 2, 1998
- Decision date
- February 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
| K983419 | Hoffmann II Miami PostHRS · Traditional | 11/25/1998SE |
Questions and answers
When was Zeta Multizone Locking Nail System cleared by the FDA?
Zeta Multizone Locking Nail System (K984305) received a 510(k) decision of Substantially Equivalent on February 1, 1999, 61 days after the submission was received.
What is the product code of K984305?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.