Acufex Suretac(R) Pac
FDA 510(k) K930538 · Acufex Microsurgical, Inc.
510(k) numberK930538
Submission
- Device name
- Acufex Suretac(R) Pac
- Applicant
- Acufex Microsurgical, Inc.
Mansfield, MA, US - Received
- February 2, 1993
- Decision date
- September 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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
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| K961555 | Acufex Tag Bioabsorbable AnchorsJDR · Traditional | 07/10/1996SE |
| K961853 | Proline Fast Pass Arthoscopic Needle PasserHRX · Traditional | 06/21/1996SE |
| K954246 | Acufex Endofix Absorbable Interference ScrewHWC · Traditional | 02/15/1996SN |
| K952535 | Acufex Endobutton TapeGAT · Traditional | 02/08/1996SN |
| K953276 | Acufex Tag Delivery SystemJDR · Traditional | 10/05/1995SE |
| K953459 | Acufex Tag AnchorMBI · Traditional | 08/23/1995SE |
| K941740 | Acufex Rotator Cuff Fixation ButtonKGS · Traditional | 06/30/1995SE |
| K944500 | Acufex Patellar Bone Block SizerHRX · Traditional | 06/12/1995SE |
| K951859 | Acufex Endobutton PackHRX · Traditional | 06/09/1995SE |
| K946346 | Acufex Tag(R) Bioabsorbable AnchorsJDR · Traditional | 04/26/1995SE |
Questions and answers
When was Acufex Suretac(R) Pac cleared by the FDA?
Acufex Suretac(R) Pac (K930538) received a 510(k) decision of Substantially Equivalent on September 13, 1993, 223 days after the submission was received.
What is the product code of K930538?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.