C.C.F. Femoral Debridement Probe
FDA 510(k) K790996 · Depuy, Inc.
510(k) numberK790996
Submission
- Device name
- C.C.F. Femoral Debridement Probe
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- May 29, 1979
- Decision date
- June 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTO – Reamer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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|---|---|---|---|
| K111437 | Synthes Ria System (Expanded Indications)HTO · Traditional | Synthes (USA) Products, LLC | 08/10/2011SE |
| K042899 | Synthes (USA) Ria System - Expanded IndicationsHTO · Traditional | Synthes (Usa) | 03/16/2005SE |
| K013527 | Modification to Synthes (USA) Reamer Irrigator Aspirator (Ria) SystemHTO · Special | Synthes (Usa) | 12/21/2001SE |
| K993335 | Synthes Reamer/Irrigator/Aspirator (Ria) SystemHTO · Traditional | Synthes (Usa) | 06/12/2000SE |
| K954915 | Flexible Intramedullary ReamerHTO · Traditional | Zimmer, Inc. | 12/28/1995SE |
| K903248 | Combination ReamerHTO · Traditional | Onyx Medical Corp. | 07/30/1990SE |
| K885100 | Mcconnell Reamer GuideHTO · Traditional | Mcconnell Orthopedic | 01/13/1989SE |
| K870845 | Warsaw Orthopedic Pointed ReamerHTO · Traditional | Warsaw Orthopedic, Inc. | 03/11/1987SE |
| K862933 | ABC-1000 Small Joint ReamersHTO · Traditional | Instrumentation Industries, Inc. | 08/18/1986SE |
| K832686 | Multiple Manual Surgical InstrumentsHTO · Traditional | Hirata Sangyo Co. USA, Inc. | 10/14/1983SE |
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| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
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Questions and answers
When was C.C.F. Femoral Debridement Probe cleared by the FDA?
C.C.F. Femoral Debridement Probe (K790996) received a 510(k) decision of Substantially Equivalent on June 27, 1979, 29 days after the submission was received.
What is the product code of K790996?
The FDA product code is HTO – Reamer, a Class I (low risk) device regulated under 21 CFR 888.4540.