Precision Osteolock Femoral Comp. Titanium Plasma
FDA 510(k) K896853 · Howmedica Corp.
510(k) numberK896853
Submission
- Device name
- Precision Osteolock Femoral Comp. Titanium Plasma
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- December 5, 1989
- Decision date
- May 2, 1990
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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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 Precision Osteolock Femoral Comp. Titanium Plasma cleared by the FDA?
Precision Osteolock Femoral Comp. Titanium Plasma (K896853) received a 510(k) decision of Substantially Equivalent for Some Indications on May 2, 1990, 148 days after the submission was received.
What is the product code of K896853?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.