Knee Instrumentation, Condylar
FDA 510(k) K781091 · Biomet, Inc.
510(k) numberK781091
Submission
- Device name
- Knee Instrumentation, Condylar
- Applicant
- Biomet, Inc.
Walker, MI, US - Received
- July 3, 1978
- Decision date
- July 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWT – Template
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4800
- Specialty
- Orthopedic
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| K894228 | Kronner Spherical CuttersHWT · Traditional | Kronner Medical | 07/23/1990SE |
| K870843 | Schultz Phalangeal Comp Trial/Metacarpal Comp TriaHWT · Traditional | Warsaw Orthopedic, Inc. | 05/27/1987SE |
| K871323 | Arthroscopic Meniscal Suture SystemHWT · Traditional | Orthopedic Systems, Inc. | 05/01/1987SE |
| K830360 | 3M Osteotomy GuideHWT · Traditional | 3M Company | 03/01/1983SE |
| K811205 | Molded Polysulfone Trial ProsthesisHWT · Traditional | Shannon Group | 05/21/1981SE |
| K771710 | Worrell Patella TemplateHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
| K771709 | Worrell Trial PatellaHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
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Questions and answers
When was Knee Instrumentation, Condylar cleared by the FDA?
Knee Instrumentation, Condylar (K781091) received a 510(k) decision of Substantially Equivalent on July 17, 1978, 14 days after the submission was received.
What is the product code of K781091?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.