510(k) K993073
- Device
- SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030
- Applicant
- BIONX IMPLANTS, LTD.
- 510(k) number
- K993073
- Product code
- MAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-12-06
- Date received
- 1999-09-14
- 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
- TUIJA ANNALA
- Address
- P.O. Box 3 Herminkatu 6-8l Tampere FI SP-33721 SP-33721
FDA Registration Numbers#
- 3014302784
- 3004638532
- 2530154
- 3016678045
- 3035366890
- 3011530718
- 3007842664
- 3012470322
- 1825034
- 3015806723
- 3012818475
- 3021393544
- 3015207155
- 3013722959
- 3022518322
- 3014252644
- 3005180920
- 3007109793
- 1054811
- 1058584
- 3013086329
- 3008102042
- 3030655570
- 3038503932
- 3014286836
- 3016948539
- 1226183
- 1017294
- 3007319107
- 3003139373
- 3022472578
- 1225798
- 3014004349
- 2183946
- 1319660
- 3003755939
- 1649390
- 3032314868
- 1220246
- 3017196117
- 3010041511
- 3013176080
- 3010375065
- 3008868758
- 3015542154
- 3003604053
- 3006498370
- 3014232239
- 9681465
- 3027339877
- 1319639
- 2246552
- 2024024
- 1000517406
- 1018470
- 1526534
- 3009905888
- 3002807310
- 3002579136
- 3009732568
- 3012358417
- 1048735
- 8031010
- 1721676
- 3005381997
- 3021336182
- 3008114965
- 3008729892
- 3020704423
- 1219930
- 9615788
- 3015453963
- 3011324393
- 3018094310
- 2031917
- 3008110533
- 3015974593
- 1061927
- 1450662
- 3010273872
Source Documents#
Other 510(k) Records For Product Code MAI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026-05-28 |
| 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 |
Legacy Summary#
summary
FDA Review#
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