ABC-1000 Small Joint Reamers
FDA 510(k) K862933 · Instrumentation Industries, Inc.
510(k) numberK862933
Submission
- Device name
- ABC-1000 Small Joint Reamers
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- August 4, 1986
- Decision date
- August 18, 1986
- 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 |
| 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 |
| 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 |
|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure GaugeCAP · Traditional | 05/01/2019SE |
| K162753 | RTC 26-C Inline Aerosol AdapterCAF · Traditional | 02/28/2017SE |
| K113644 | Pilot Tube Repair KitBSK · Special | 01/26/2012SE |
| K102127 | Endotracheal Tube ChangersLNZ · Special | 08/27/2010SE |
| K101857 | RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-VCAF · Special | 07/22/2010SE |
| K091111 | RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter…CAF · Traditional | 12/02/2009SE |
| K081778 | NS Series Vacuum/Pressure Gauges, Cuff Pressure MonitorsCAP · Traditional | 09/12/2008SE |
| K081693 | NS Series Nif (Negative Inspiratory Force) MetersBXR · Traditional | 09/11/2008SE |
| K991355 | Metered Dose Inhaler Adapter-Disposable, Adapter ReusableCAF · Traditional | 01/27/2000SE |
| K992670 | Oxygen Enrichment Kit, Models SG 066, SG 067CBK · Traditional | 09/17/1999ST |
Questions and answers
When was ABC-1000 Small Joint Reamers cleared by the FDA?
ABC-1000 Small Joint Reamers (K862933) received a 510(k) decision of Substantially Equivalent on August 18, 1986, 14 days after the submission was received.
What is the product code of K862933?
The FDA product code is HTO – Reamer, a Class I (low risk) device regulated under 21 CFR 888.4540.