LM Bone Anchor (Orthopedics)
FDA 510(k) K963812 · Li Medical Technologies, Inc.
510(k) numberK963812
Submission
- Device name
- LM Bone Anchor (Orthopedics)
- Applicant
- Li Medical Technologies, Inc.
Shelton, CT, US - Received
- September 9, 1996
- Decision date
- November 12, 1996
- 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
Other 510(k)s with product code MBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | Smith & Nephew, Inc. | 07/09/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | Arthrex, Inc. | 06/26/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K002413 | Ultrasorb Suture AnchorMAI · Traditional | 09/19/2000SE |
| K993373 | Rotorblade Suture AnchorMAI · Special | 10/27/1999SE |
| K992938 | Rotorblade Suture AnchorMAI · Special | 09/23/1999SE |
| K983435 | RotorbladeMAI · Abbreviated | 04/29/1999SE |
| K981764 | LM AnchorMBI · Abbreviated | 07/13/1998SE |
| K981755 | LM AnchorMBI · Abbreviated | 07/13/1998SE |
| K963288 | LM Bone AnchorMBI · Traditional | 11/13/1996SE |
| K960825 | LM Anchor or Other Proprietary NameMBI · Traditional | 04/30/1996SE |
| K960439 | LM Bone AnchorMBI · Traditional | 04/18/1996SE |
| K960448 | LM AnchorMBI · Traditional | 04/17/1996SE |
Questions and answers
When was LM Bone Anchor (Orthopedics) cleared by the FDA?
LM Bone Anchor (Orthopedics) (K963812) received a 510(k) decision of Substantially Equivalent on November 12, 1996, 64 days after the submission was received.
What is the product code of K963812?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.