510(k) K110879
- Device
- BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
- Applicant
- BIOMET SPORTS MEDICINE
- 510(k) number
- K110879
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-08-19
- Date received
- 2011-03-30
- 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
- ELIZABETH WRAY
- Address
- 56 E. Bell Dr., P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3015869493
- 3003755939
- 3015231789
- 3013843230
- 2031917
- 3025141
- 3006783837
- 3010047402
- 3024856795
- 3021336182
- 3022393834
- 1221601
- 3012883081
- 1319660
- 1048735
- 1835296
- 3014967969
- 2648666
- 1047843
- 2530154
- 3035366890
- 3015131017
- 3013302242
- 3004579081
- 3043861298
- 3009417901
- 3011410128
- 3010123256
- 3008868758
- 1017294
- 2648623
- 3026368553
- 3010392243
- 1643264
- 3015151147
- 3003139373
- 1649518
- 3027071765
- 3030926959
- 2031093
- 3016084569
- 1721676
- 3010375065
- 3010673515
- 8043734
- 9681465
- 3000270450
- 3038503932
- 2246552
- 3009227834
- 3006563559
- 3010060157
- 3008114965
- 1054811
- 3027242374
- 3014262693
- 3005381997
- 3017528621
- 3016660811
- 1828288
- 3006498370
- 3030514683
- 3029312837
- 1064017
- 3010178296
- 3005543241
- 1018470
- 3017196117
- 3010162973
- 3014004349
- 1649390
- 3009540749
- 3027454646
- 3009423112
- 1835251
- 2183967
- 3012329552
- 3045178691
- 3011324393
Source Documents#
Other 510(k) Records For Product Code MBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260405 | FiberTape Button | Arthrex, Inc. | 2026-03-09 |
| K253538 | TeKBrace Knotless Anchor | Theramicro | 2026-03-06 |
Legacy Summary#
summary
FDA Review#
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