Microguard, Orthopedic Pin Protectors
FDA 510(k) K902676 · Micro-Aire Surgical Instruments, Inc.
510(k) numberK902676
Submission
- Device name
- Microguard, Orthopedic Pin Protectors
- Applicant
- Micro-Aire Surgical Instruments, Inc.
Valencia, CA, US - Received
- June 19, 1990
- Decision date
- September 14, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYT – Fixation Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040363 | Ceramic Tipped Skull PinLYT · Traditional | The Jerome Group, Inc. | 04/12/2004SE |
| K983685 | Bone BandLYT · Traditional | Chapel and Assoc. | 12/04/1998SE |
| K980594 | Osteonics Fx-Cablelok Grip ComponentsLYT · Traditional | Osteonics Corp. | 05/05/1998SE |
| K914812 | K-Cap-E, SterileLYT · Traditional | Westcon Orthopedics, Inc. | 01/09/1992SE |
| K912762 | K-Cap-I, SterileLYT · Traditional | Westcon Orthopedics, Inc. | 07/18/1991SE |
| K902053 | K-Cap-I Orthopedic Fixation Wire CapLYT · Traditional | Westcon Orthopedics, Inc. | 09/14/1990SE |
| K883576 | Horizon Orthopedic Pin ProtectorLYT · Traditional | Horizon Medical, Inc. | 09/30/1988SE |
| K831072 | Jurgan Pin BallLYT · Traditional | Jurgan Development & Mfg., Ltd. | 06/08/1983SE |
More from Jurgan Development & Mfg., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K904949 | A.O. Synthes,Tap(Replacement)Various Model NumbersHSZ · Traditional | 11/26/1990SE |
| K903713 | Osteotome Model Numbers 2500-228 & 2500-229HSZ · Traditional | 09/14/1990SE |
| K903650 | Oscillating Saw Blades # SO-305,MO-305 and ZO-305HWE · Traditional | 09/14/1990SE |
| K903664 | Micro-Aire Wire Pass and Craniotome DrillHBE · Traditional | 09/13/1990SE |
| K901967 | Dendia Werk Burs and Cutting DiscsDZP · Traditional | 07/13/1990SE |
| K902168 | Arthroscopic Surgery Blades (Several Models)HRX · Traditional | 06/20/1990SE |
| K901735 | Arthroscopic Surgery Blades DY-3440, 3443, 3444HRX · Traditional | 06/20/1990SE |
| K900033 | Micro-Aire Powered Micro-Surgery InstrumentsGEY · Traditional | 02/13/1990SE |
| K900210 | Bone Harvester System & Osteotome System 2500HSZ · Traditional | 02/02/1990SE |
| K896280 | Micro-Aire Oscillating Saw Blade 202C-25, 202C-50GFA · Traditional | 11/22/1989SE |
Questions and answers
When was Microguard, Orthopedic Pin Protectors cleared by the FDA?
Microguard, Orthopedic Pin Protectors (K902676) received a 510(k) decision of Substantially Equivalent on September 14, 1990, 87 days after the submission was received.
What is the product code of K902676?
The FDA product code is LYT – Fixation Accessory, a Class II (moderate risk) device regulated under 21 CFR 888.3030.