Micro/Mini N-Pk(H) Bone Anchor
FDA 510(k) K121356 · Anulex Technologies, Inc.
510(k) numberK121356
Submission
- Device name
- Micro/Mini N-Pk(H) Bone Anchor
- Applicant
- Anulex Technologies, Inc.
Minnetonka, MN, US - Received
- May 4, 2012
- Decision date
- November 9, 2012
- 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 |
|---|---|---|
| K121354 | Micro/Mini N-Pk(F) Bone AnchorMBI · Traditional | 11/09/2012SE |
| K113805 | Fixate Tissue BandGZB · Traditional | 02/23/2012SE |
| K113400 | Fixate Tissue BandGZB · Special | 12/16/2011SE |
| K112849 | Fixate Tissue BandGZB · Special | 10/27/2011SE |
| K111462 | Fixate Tissue BandGZB · Traditional | 09/08/2011SE |
| K100572 | Versaclose, Model VC-200-01GAT · Special | 03/17/2010SE |
| K091432 | Xclose Tissue Repair System, Model XC-200-01GAT · Special | 06/12/2009SE |
| K082729 | Rimclose Bone AnchorMBI · Traditional | 12/19/2008SE |
| K062307 | Xclose Tissue Repair System, Model SRSGAT · Special | 09/01/2006SE |
| K061386 | Anchor Band Suturing System, Model Sr-AbGAT · Traditional | 07/05/2006SE |
Questions and answers
When was Micro/Mini N-Pk(H) Bone Anchor cleared by the FDA?
Micro/Mini N-Pk(H) Bone Anchor (K121356) received a 510(k) decision of Substantially Equivalent on November 9, 2012, 189 days after the submission was received.
What is the product code of K121356?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.