510(k) K260921
- Device
- Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
- Applicant
- Tigon Medical
- 510(k) number
- K260921
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-21
- Date received
- 2026-03-19
- Regulation
- 888.3040
- Classification name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jeremy Clark
- Address
- 303 Najoles Rd., Suite 104 Millersville MD US 21108 21108
FDA Registration Numbers#
- 3043620689
- 3014315560
- 3005497913
- 1721676
- 3027339877
- 3010692967
- 3013302242
- 3006946276
- 3010047454
- 3025318945
- 3016948539
- 3007093114
- 9681465
- 1220246
- 3013843230
- 3038185071
- 3034676720
- 1320894
- 3033273526
- 3010667733
- 1920664
- 3006498370
- 1834331
- 3016660811
- 3010178296
- 3011230048
- 3006783837
- 3027978412
- 3017034897
- 3013111980
- 2936485
- 3011530718
- 3008729892
- 3010375065
- 3020704423
- 3015173212
- 1221934
- 2649614
- 3003236702
- 3021226419
- 3015724777
- 3012329552
- 3003477135
- 3014302784
- 3015075784
- 3005941719
- 3012883081
- 3008262872
- 3027242374
- 1221601
- 1064017
- 1527105
- 3016084569
- 3009423112
- 1526534
- 3010163695
- 1043534
- 3010400367
- 1649518
- 3020899789
- 3014763043
- 3043861298
- 2024311
- 3030188041
- 3011061237
- 3014680795
- 3016926753
- 3009971621
- 3021393544
- 3007319107
- 3005064037
- 3015200759
- 3008599979
- 1835572
- 1047843
- 3045178691
- 3013767421
- 3038503932
- 3026368553
- 1222274
Source Documents#
Other 510(k) Records For Product Code MBI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253065 | Aevumed SUPERCYNCH™ Button System | Aevumed, Inc. | 2026-09-02 |
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-09-02 |
| K262677 | Iconix Knotless T | Riverpoint Medical | 2026-08-27 |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | 2026-07-30 |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | 2026-07-20 |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | 2026-07-09 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026-06-26 |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| K261363 | Y-Knotless™ 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 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-20 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 |