Synthes (USA) Ria System - Expanded Indications
FDA 510(k) K042899 · Synthes (Usa)
510(k) numberK042899
Submission
- Device name
- Synthes (USA) Ria System - Expanded Indications
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- October 20, 2004
- Decision date
- March 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTO – Reamer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111437 | Synthes Ria System (Expanded Indications)HTO · Traditional | Synthes (USA) Products, LLC | 08/10/2011SE |
| 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 |
| K811081 | Medullary Canal ScrapersHTO · Traditional | The Anspach Effort, Inc. | 04/29/1981SE |
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Questions and answers
When was Synthes (USA) Ria System - Expanded Indications cleared by the FDA?
Synthes (USA) Ria System - Expanded Indications (K042899) received a 510(k) decision of Substantially Equivalent on March 16, 2005, 147 days after the submission was received.
What is the product code of K042899?
The FDA product code is HTO – Reamer, a Class I (low risk) device regulated under 21 CFR 888.4540.