G/K SFN and STN Locking Nails
FDA 510(k) K983358 · Howmedica, Inc.
510(k) numberK983358
Submission
- Device name
- G/K SFN and STN Locking Nails
- Applicant
- Howmedica, Inc.
Rutherford, NJ, US - Received
- September 24, 1998
- Decision date
- November 18, 1998
- 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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|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
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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 |
Questions and answers
When was G/K SFN and STN Locking Nails cleared by the FDA?
G/K SFN and STN Locking Nails (K983358) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 55 days after the submission was received.
What is the product code of K983358?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.