510(k) K231002
- Device
- Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
- Applicant
- Suzhou Endophix Co., Ltd.
- 510(k) number
- K231002
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-07
- Date received
- 2023-04-07
- Regulation
- 888.3040
- Classification name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Jaun Wu
- Address
- # 151, Fengli Rd. Suzhou CN 215000 215000
FDA Registration Numbers
- 3024021261
- 3014273424
- 3015173212
- 3004549189
- 3014262693
- 2024311
- 3017499940
- 2029275
- 3026368553
- 3005064037
- 1000484830
- 3006563559
- 3006981798
- 3008650117
- 3003898228
- 3014763043
- 3017034897
- 3013756169
- 2244478
- 3009826895
- 3038185071
- 1835444
- 1423662
- 3021008900
- 3013404959
- 3000203391
- 3015974593
- 3020584246
- 3013700547
- 3010392243
- 3016851379
- 3007842664
- 3019269298
- 2320767
- 2649614
- 2648623
- 3010303097
- 3010400367
- 3008110533
- 3007304202
- 3010047454
- 3017196117
- 3025318945
- 3014004349
- 3008034554
- 3007993775
- 3010202439
- 1047843
- 3002907620
- 3009971621
- 3018094310
- 2936485
- 2011171
- 3012883081
- 3010331645
- 3010863450
- 1043653
- 3043861298
- 3008749819
- 3012755988
- 3015075784
- 3009540749
- 3011324393
- 1048735
- 2530154
- 3022393834
- 3008868758
- 3014315560
- 2245304
- 3043620689
- 3005543241
- 2183967
- 3012470322
- 3011301313
- 1018470
- 3008262872
- 3009756327
- 3012103978
- 3010531069
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06974940305362 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305287 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305294 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305300 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305317 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305324 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305331 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305348 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305355 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305447 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305379 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305386 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305393 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305409 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305416 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305423 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
| 06974940305430 | endophix | Suzhou Endophix Co., Ltd. | 2025-12-05 |
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|---|---|---|---|
| K261363 | Y-KnotlessĀ Flex Anchors | CONMED Corporation | 2026-05-13 |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026-05-06 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-05-01 |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026-04-21 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-20 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 |
| K254176 | SINEFIX | BAAT Medical Products B.V. | 2026-03-16 |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | 2026-03-12 |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | 2026-03-11 |
| K260405 | FiberTape Button | Arthrex, Inc. | 2026-03-09 |
| K253538 | TeKBrace Knotless Anchor | Theramicro | 2026-03-06 |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-02 |
| K253695 | LigaMend | Riverpoint Medical, LLC | 2026-02-27 |
| K253763 | Y-KnotlessĀ Flex Anchors | Conmed Corporation | 2026-01-29 |