510(k) K152566
- Device
- PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification To Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture A
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K152566
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-02
- Date received
- 2015-09-09
- 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
Applicant Contact#
- Contact
- KATHERINE MARCACCIO
- Address
- 130 Forbes Blvd. Mansfield MA US 02048 02048
FDA Registration Numbers#
- 3014162916
- 3010375065
- 3020584246
- 2245304
- 3027454646
- 2649614
- 3007304202
- 8044102
- 1526711
- 3014004349
- 1222928
- 2011171
- 3014232239
- 3025141
- 1219602
- 1834379
- 3030412764
- 3020899789
- 3011230048
- 3030926959
- 3011295718
- 3017499940
- 2320767
- 3003477135
- 3004944585
- 3008729892
- 3006990600
- 3008868758
- 3010162973
- 3007420745
- 3015173212
- 2031917
- 2183967
- 3010060157
- 3015453963
- 1054811
- 2030624
- 8043734
- 3014315560
- 3014967969
- 3006524618
- 3016926753
- 3038185071
- 1313525
- 3027339877
- 3007319107
- 3009971621
- 3010123256
- 3010163695
- 1221934
- 3006809628
- 3011324393
- 3006783837
- 3007993775
- 2648666
- 1527105
- 3014302784
- 3013722959
- 3008749819
- 2183744
- 3006638824
- 3015216945
- 8043792
- 3007093114
- 3004142400
- 3016851379
- 3014680795
- 3003604053
- 1450662
- 1226146
- 8020712
- 2031093
- 3009227834
- 3004579081
- 3030514683
- 3021008900
- 3010667733
- 3013365802
- 3013176080
Source Documents#
Other 510(k) Records For Product Code MBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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