Howmedica Precis Osteolock Fem Comp W/Hydro Coat
FDA 510(k) K912395 · Howmedica Corp.
510(k) numberK912395
Submission
- Device name
- Howmedica Precis Osteolock Fem Comp W/Hydro Coat
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- May 28, 1991
- Decision date
- July 24, 1991
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
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| K251052 | Trivicta® Hip StemMEH · Traditional | Ortho Development Corp. | 05/22/2025SE |
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| K243162 | World LinerMEH · Special | Signature Orthopaedics Pty, Ltd. | 11/25/2024SE |
| K241472 | Icona Hip StemMEH · Traditional | Corin U.S.A. Limited | 10/03/2024SE |
| K241875 | TheRay Collared and Collarless Femoral StemMEH · Traditional | Nextstep Arthropedix | 09/13/2024SE |
| K241690 | Logical Liner; World Liner; World Knee PatellaMEH · Special | Signature Orthopaedics Pty, Ltd. | 08/01/2024SE |
More from Signature Orthopaedics Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| 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 Howmedica Precis Osteolock Fem Comp W/Hydro Coat cleared by the FDA?
Howmedica Precis Osteolock Fem Comp W/Hydro Coat (K912395) received a 510(k) decision of Substantially Equivalent for Some Indications on July 24, 1991, 57 days after the submission was received.
What is the product code of K912395?
The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.