Ogden Anchor-Small (Tentative)
FDA 510(k) K941029 · American Medical Electronics, Inc.
510(k) numberK941029
Submission
- Device name
- Ogden Anchor-Small (Tentative)
- Applicant
- American Medical Electronics, Inc.
Richardson, TX, US - Received
- March 7, 1994
- Decision date
- February 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| K951232 | Expanded Range of Suture Sizes Ogden Anchors: 7.4MM and 5.5MMHWC · Traditional | 08/25/1995SE |
| K952348 | Ogden AnchorJDR · Traditional | 08/21/1995SE |
| K950875 | Ogden AnchorHWC · Traditional | 07/11/1995SE |
| K951545 | Ogden Anchor for All Orthopaedic Soft Tissue ApplicationsHWC · Traditional | 07/03/1995SE |
| K951493 | Ogden AnchorHWC · Traditional | 07/03/1995SE |
| K931381 | Ame Universal Fixation SystemKWP · Traditional | 02/01/1995SN |
| K935065 | Ogden Anchor Additional ApplicationsJDR · Traditional | 01/30/1995SE |
| K942300 | Silkon Titanium Cable SystemJDQ · Traditional | 01/09/1995SESK |
| K935167 | Ogden Anchor (Modification)JDR · Traditional | 07/12/1994SN |
| K932687 | Ame(R) Universial Cable SystemJDQ · Traditional | 05/03/1994SE |
Questions and answers
When was Ogden Anchor-Small (Tentative) cleared by the FDA?
Ogden Anchor-Small (Tentative) (K941029) received a 510(k) decision of Substantially Equivalent on February 9, 1995, 339 days after the submission was received.
What is the product code of K941029?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.