Sternal Power Awl
FDA 510(k) K873766 · Bowen & Company, Inc.
510(k) numberK873766
Submission
- Device name
- Sternal Power Awl
- Applicant
- Bowen & Company, Inc.
Rockville, MD, US - Received
- September 16, 1987
- Decision date
- November 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K163308 | SmartoKIJ · Special | Jeil Medical Corporation | 12/27/2016SE |
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| K101563 | SmartoKIJ · Traditional | Jeil Medical Corporation | 12/17/2010SE |
| K972367 | Stryker System 4000 Heavy Duty Battery Powered EquipmentKIJ · Traditional | Stryker Instruments | 09/04/1997SE |
| K970378 | Stryker 2115 Replacement Battery (2115)KIJ · Traditional | Implant Resource, Inc. | 04/30/1997SE |
| K960711 | Acumed Bone Graft SystemKIJ · Traditional | Acu Med, Inc. | 05/07/1996SE |
| K951450 | System 2000 Replacement Battery, System 2000-EXTENDED Run Replacement BatteryKIJ · Traditional | Strenumed, Inc. | 05/17/1995SE |
| K944488 | S & S Orthopedic Wire Driver 701KIJ · Traditional | S & S Orthopedic , Ltd. | 03/02/1995SE |
| K941285 | Arthrex Graft Harvesting KitKIJ · Traditional | Arthrex, Inc. | 11/14/1994SE |
| K933101 | The Osteomed B Power System and AccessoriesKIJ · Traditional | Osteomed Corp. | 11/07/1994SE |
More from Osteomed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | 04/04/1990SE |
| K896538 | Disposable 45 Degree ShaverHRX · Traditional | 12/06/1989SE |
| K872098 | Cremeen Alveolar Bone CaliperEIL · Traditional | 07/31/1987SE |
| K871325 | Bowen Reuseable/Disposable ElectrodeDRX · Traditional | 06/08/1987SE |
| K870882 | 45 Degree ShaverHTZ · Traditional | 03/23/1987SE |
| K870881 | Loose Body GraspersHTD · Traditional | 03/23/1987SE |
| K863150 | Bowen CannulaGEA · Traditional | 09/05/1986SE |
| K863149 | Bowen ProbeHXB · Traditional | 09/05/1986SE |
| K863148 | Bowen Knot PasserHXI · Traditional | 09/05/1986SE |
| K863147 | Glenoid DrillHTW · Traditional | 09/05/1986SE |
Questions and answers
When was Sternal Power Awl cleared by the FDA?
Sternal Power Awl (K873766) received a 510(k) decision of Substantially Equivalent on November 14, 1988, 425 days after the submission was received.
What is the product code of K873766?
The FDA product code is KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.