510(k) K994364
- Device
- SYNTHES BUTTON PLATE
- Applicant
- SYNTHES (USA)
- 510(k) number
- K994364
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-15
- Date received
- 1999-12-27
- 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
- SHERI L MUSGNUNG
- Address
- 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 3016926753
- 3006990600
- 3010667733
- 1720929
- 3008837339
- 2183946
- 1221934
- 3007304202
- 3034676720
- 3006272282
- 3005497913
- 3006524618
- 3007993775
- 3012103978
- 1043534
- 1220477
- 2245304
- 3014004349
- 3013843230
- 3008114965
- 3015724777
- 3021226419
- 1220246
- 3021008900
- 1047843
- 3015806723
- 3014273424
- 3017210488
- 3004983210
- 8044102
- 3010303097
- 2030624
- 3011410128
- 1219930
- 1835296
- 3012329552
- 3010400367
- 3010123256
- 1048735
- 3012883081
- 3014967969
- 3024021261
- 3006498370
- 3010392243
- 2320767
- 2183967
- 2246552
- 3016851379
- 3011683674
- 3010273872
- 3016084569
- 1222928
- 2090040
- 3005543241
- 3022393834
- 3013700547
- 1000484830
- 3009756327
- 3013365802
- 2649614
- 2650143
- 3002579136
- 3026368553
- 3014315560
- 3018094310
- 3017196117
- 1834331
- 1835444
- 3011230048
- 3027339877
- 2024311
- 3004549189
- 1225492
- 3005381997
- 3003898228
- 1920664
- 1320894
- 3008599979
- 2244478
Source Documents#
Other 510(k) Records For Product Code MBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 |
Legacy Summary#
summary
FDA Review#
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