Combination Reamer
FDA 510(k) K903248 · Onyx Medical Corp.
510(k) numberK903248
Submission
- Device name
- Combination Reamer
- Applicant
- Onyx Medical Corp.
Memphis, TN, US - Received
- July 24, 1990
- Decision date
- July 30, 1990
- 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
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 |
| 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 |
| 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 |
More from The Anspach Effort, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K041679 | Cold Light; Cold Light MD; Gossamer DermlightILY · Abbreviated | 12/16/2004SE |
| K942022 | Face-It ShieldLYU · Traditional | 07/08/1994SE |
| K931690 | Spoon PlateHRS · Traditional | 06/07/1994SN |
| K934614 | Mini Fragment PlateHRS · Traditional | 05/04/1994SN |
| K931692 | T-PlateHRS · Traditional | 05/04/1994SN |
| K931684 | Epiphysis PlateHRS · Traditional | 05/04/1994SN |
| K931680 | Cannulated Cancellous ScrewHWC · Traditional | 05/04/1994SN |
| K934616 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K934615 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K931790 | Cortical Bone ScrewHWC · Traditional | 04/25/1994SN |
Questions and answers
When was Combination Reamer cleared by the FDA?
Combination Reamer (K903248) received a 510(k) decision of Substantially Equivalent on July 30, 1990, 6 days after the submission was received.
What is the product code of K903248?
The FDA product code is HTO – Reamer, a Class I (low risk) device regulated under 21 CFR 888.4540.