Short Straight-In Bone Screw Fixation System
FDA 510(k) K982155 · Influence, Inc.
510(k) numberK982155
Submission
- Device name
- Short Straight-In Bone Screw Fixation System
- Applicant
- Influence, Inc.
Washington, DC, US - Received
- June 18, 1998
- Decision date
- August 31, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K981677 | Repose Bone Screw SystemLRK · Traditional | 08/27/1999SE |
| K991792 | Cryo-Mono Cryogenic System, Model Cryo-Mono with Tuf ProbeGEH · Traditional | 08/12/1999SE |
| K992277 | Stapletac Bone Anchor SystemHWC · Special | 07/30/1999SE |
| K991122 | Cryo-Mono Cryogrnic SystemGEH · Traditional | 07/01/1999SE |
| K990160 | Microtac-Bone Anchor SystemMBI · Special | 02/16/1999SE |
| K990095 | Straight-In-Orthopedic Bone Screw Fixation SystemMBI · Traditional | 02/01/1999SE |
| K983325 | In-Probe II Urodynamic SystemFEN · Traditional | 11/24/1998SE |
| K981631 | Influence Clip SystemFZP · Traditional | 07/28/1998SE |
| K980482 | Triangle SlingOTN · Traditional | 03/27/1998SE |
| K972622 | Straight-In Bone Screw Fixation SystemMBI · Traditional | 10/09/1997SE |
Questions and answers
When was Short Straight-In Bone Screw Fixation System cleared by the FDA?
Short Straight-In Bone Screw Fixation System (K982155) received a 510(k) decision of Substantially Equivalent on August 31, 1998, 74 days after the submission was received.
What is the product code of K982155?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.