Danek Irrigating Burr (Dib) Set
FDA 510(k) K890090 · Danek Medical, Inc.
510(k) numberK890090
Submission
- Device name
- Danek Irrigating Burr (Dib) Set
- Applicant
- Danek Medical, Inc.
Memphis, TN, US - Received
- January 10, 1989
- Decision date
- January 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFF – Bur, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GFF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974025 | Anspach Shielded AttachmentGFF · Traditional | The Anspach Effort, Inc. | 07/06/1998SE |
| K950449 | Surgical BurGFF · Traditional | Transidyne General Corp. | 03/01/1995SE |
| K943758 | Surgical BurGFF · Traditional | Komet Medical | 08/22/1994SE |
| K934583 | BurrsGFF · Traditional | American Medical Specialties, Inc. | 01/26/1994SE |
| K894438 | Micro-Aire Cutters for Midas-Rex InstrumentsGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 08/21/1989SE |
| K883255 | Komet Surgical BurGFF · Traditional | Komet Medical, Div. of Brasseler USA I, L.P. | 09/15/1988SE |
| K880859 | Surgical BursGFF · Traditional | New England Surgical Instrument Corp. | 03/21/1988SE |
| K880706 | Surgical BursGFF · Traditional | Nuell Air Equipment & Hospital Supplies, Inc. | 02/26/1988SE |
| K872475 | Surgical BurGFF · Traditional | Tava Surgical Instruments | 07/02/1987SE |
| K862852 | Micro-Aire Replace Otology Burs/Zim Hall Sur InstrGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 08/11/1986SE |
More from Micro-Aire Surgical Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994122 | Bone Graft Washer, Model 9090114 - 9090118KWQ · Traditional | 02/18/2000SE |
| K993810 | CD Horizon Spinal SystemMNH · Special | 02/03/2000SE |
| K993855 | Atlantis Anterior Cervical Plate SystemKWQ · Special | 12/15/1999SE |
| K991528 | Modification to Tenor Spinal System-Rod/Bolt ConnectorMNH · Special | 05/28/1999SE |
| K990603 | Modification of the Zplate-Atl Anterior Fixation SystemKWQ · Special | 03/10/1999SE |
| K982875 | Modification to Zplate-Atl Anterior Fixation SystemKWQ · Special | 01/19/1999SE |
| K984522 | Modification of TSRH Spinal SystemMNI · Special | 01/06/1999SE |
| K982154 | Modification of Townley Pedicle Screw Plating SystemMNI · Special | 07/13/1998SE |
| K970599 | Townley Pedicle Screw Plating SystemMNI · Traditional | 03/20/1998SE |
| K943827 | Spine FixationMNH · Traditional | 02/14/1996SN |
Questions and answers
When was Danek Irrigating Burr (Dib) Set cleared by the FDA?
Danek Irrigating Burr (Dib) Set (K890090) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 14 days after the submission was received.
What is the product code of K890090?
The FDA product code is GFF – Bur, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4820.