510(k) K193606
- Device
- Y-Knot OneStep Anchor
- Applicant
- ConMed Corporation
- 510(k) number
- K193606
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-01-22
- Date received
- 2019-12-23
- 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
- No
Applicant Contact#
- Contact
- Carrie Engleman
- Address
- 525 French Rd. Utica NY US 13502 13502
FDA Registration Numbers#
- 3014315560
- 3014262693
- 3008812560
- 3045178691
- 3016678045
- 1064017
- 1834379
- 3010392243
- 1221601
- 3010400367
- 3021226419
- 1835444
- 3020899789
- 3034676720
- 3004944585
- 9613350
- 3004142400
- 3027339877
- 1313525
- 3012818475
- 3015539532
- 2020550
- 3021632375
- 2183967
- 1835296
- 3017210488
- 3015173212
- 3024856795
- 3005381997
- 1720929
- 3014763043
- 3005941719
- 3005497913
- 3015724777
- 9681465
- 1417592
- 1226183
- 1226146
- 1043534
- 3010375065
- 3004549189
- 3013302242
- 3016084569
- 2530154
- 3016926753
- 3013111980
- 3010155661
- 3025318945
- 3006783837
- 3006108336
- 3029312837
- 3003477135
- 3012103978
- 3021008900
- 3007304202
- 3016851379
- 2031093
- 3006638824
- 2032098
- 3008729892
- 1424263
- 3015207155
- 3015200759
- 3010047454
- 3006563559
- 3009423112
- 3014232239
- 3027071765
- 3010123256
- 3002579136
- 3006498370
- 1824313
- 2090040
- 3008749819
- 3011580264
- 1000484830
- 3019269298
- 3000270450
- 3011230048
Source Documents#
Other 510(k) Records For Product Code MBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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