510(k) K130917
- Device
- HEALIX ADVANCE KNOTLESS BR ANCHOR
- Applicant
- DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
- 510(k) number
- K130917
- Product code
- MAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-24
- Date received
- 2013-04-03
- Regulation
- 888.3030
- Classification name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- YAYOI FUJIMAKI
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3024021261
- 3015173212
- 3014262693
- 3004549189
- 3022472578
- 2024024
- 3005064037
- 3006981798
- 9610612
- 3015974593
- 9610622
- 3013700547
- 3016851379
- 8010177
- 3007842664
- 3019269298
- 3010400367
- 3008110533
- 3017196117
- 3025318945
- 3014004349
- 1047843
- 2936485
- 3002907620
- 3018094310
- 2032830
- 3012883081
- 3010331645
- 1048735
- 3011324393
- 2530154
- 3008868758
- 2245304
- 2183967
- 3012470322
- 3001592626
- 3015543569
- 1018470
- 1219930
- 9710629
- 3008729892
- 8043792
- 3014560508
- 3022518322
- 1836357
- 1220477
- 3027339877
- 3011530718
- 3015231789
- 3008812560
- 3015780293
- 3010273872
- 8031010
- 3005180920
- 3010375065
- 3030655570
- 9615788
- 3004983210
- 1061927
- 1825034
- 2031917
- 2183946
- 3015453963
- 1221934
- 3011230048
- 3015539532
- 3006990600
- 3010162973
- 3021226419
- 3009905888
- 1526534
- 1221051
- 3007109793
- 1017294
- 3004365956
- 3015724777
- 3013086329
- 3007193505
- 1220246
Source Documents#
Other 510(k) Records For Product Code MAI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | 2026-03-27 |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2026-02-24 |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | 2026-02-17 |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025-10-15 |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | 2025-08-19 |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2025-05-27 |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | 2025-05-23 |
| K250528 | Stryker AlphaVent™ Knotless SP Biocomposite Anchor | Stryker Endoscopy | 2025-05-21 |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. | 2025-04-03 |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. | 2025-03-14 |
| K243790 | GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor | Depuy Mitek | 2025-02-05 |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | 2024-12-03 |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | Depuy Mitek | 2024-09-11 |
| K241912 | BIOCHARGE | Nanofiber Solutions, LLC | 2024-07-29 |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | Arthrex, Inc. | 2024-06-04 |
Legacy Summary#
summary
FDA Review#
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