Litwin Cruicate Anchor
FDA 510(k) K002600 · Instrument Makar, Inc.
510(k) numberK002600
Submission
- Device name
- Litwin Cruicate Anchor
- Applicant
- Instrument Makar, Inc.
Okemos, MI, US - Received
- August 21, 2000
- Decision date
- November 15, 2000
- 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 |
|---|---|---|
| K980999 | ST Leger Cemented Semi-Constrained Total Knee ImplantJWH · Traditional | 11/06/1998SE |
| K963396 | Biosphere Suture AnchorMAI · Traditional | 05/06/1997SE |
| K964364 | Disposable ApronLYU · Traditional | 02/25/1997SE |
| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | 11/19/1996SE |
| K960555 | Bioasbsorbable Mini-Screw Suture AnchorMAI · Traditional | 07/09/1996SE |
| K943249 | Bioabsorbable Interference ScrewMAI · Traditional | 07/31/1995SE |
| K944062 | Laprascopic GrasperGCS · Traditional | 02/23/1995SE |
| K942828 | Makar Full and Half Face ShieldLYU · Traditional | 02/23/1995SE |
| K930980 | Instrument Makar Perfix Interference Bone ScrewHWC · Traditional | 02/10/1994SN |
| K923841 | Bone ScrewsHWC · Traditional | 10/27/1993SE |
Questions and answers
When was Litwin Cruicate Anchor cleared by the FDA?
Litwin Cruicate Anchor (K002600) received a 510(k) decision of Substantially Equivalent on November 15, 2000, 86 days after the submission was received.
What is the product code of K002600?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.