Alta Non-Reamed Tibial Rod
FDA 510(k) K884500 · Howmedica Corp.
510(k) numberK884500
Submission
- Device name
- Alta Non-Reamed Tibial Rod
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- October 26, 1988
- Decision date
- January 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| 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 Alta Non-Reamed Tibial Rod cleared by the FDA?
Alta Non-Reamed Tibial Rod (K884500) received a 510(k) decision of Substantially Equivalent on January 18, 1989, 84 days after the submission was received.
What is the product code of K884500?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.