Peba Anchor (Multiple Sizes)
FDA 510(k) K951451 · Orthopaedic Biosystems, Ltd.
510(k) numberK951451
Submission
- Device name
- Peba Anchor (Multiple Sizes)
- Applicant
- Orthopaedic Biosystems, Ltd.
Scotsdale, AZ, US - Received
- March 29, 1995
- Decision date
- October 31, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01JDR · Special | 04/03/2000SE |
| K982996 | Polymer Obl SB Anchor / Suture CombinationJDR · Traditional | 03/04/1999SE |
| K983169 | Polymer Threaded AnchorMBI · Traditional | 12/16/1998SE |
| K982963 | Polymer Threaded Anchor / Suture CombinationJDI · Traditional | 11/20/1998SE |
| K972326 | Peba Anchor/Suture CombinationMBI · Traditional | 02/06/1998SE |
| K963420 | Cancellous Screw WasherHTN · Traditional | 11/15/1996SE |
| K963432 | Guide Wires for Cannulated ScrewsLXT · Traditional | 11/13/1996SE |
| K963433 | Threaded Fixation PinJDW · Traditional | 11/06/1996SE |
| K962779 | Compression ScrewHWC · Traditional | 08/23/1996SN |
| K942889 | SB AnchorJDR · Traditional | 08/25/1995SE |
Questions and answers
When was Peba Anchor (Multiple Sizes) cleared by the FDA?
Peba Anchor (Multiple Sizes) (K951451) received a 510(k) decision of Substantially Equivalent for Some Indications on October 31, 1995, 216 days after the submission was received.
What is the product code of K951451?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.