510(k) K092998
- Device
- CONMED LINVATEC INTERCEPT IMPLANT
- Applicant
- LINVATEC CORP.
- 510(k) number
- K092998
- Product code
- MBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-23
- Date received
- 2009-09-28
- 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
- DIONNE SANDERS
- Address
- 11311 Concept Blvd. Largo FL US 33773 33773
FDA Registration Numbers#
- 3014302784
- 3015216945
- 3013767421
- 3010060157
- 2530154
- 3011301313
- 1424263
- 3016678045
- 1043534
- 3035366890
- 3011530718
- 3007420745
- 3007842664
- 3012470322
- 1935627
- 1825034
- 3008749819
- 3020584246
- 3012818475
- 3015806723
- 3021393544
- 3015207155
- 3009971621
- 3013722959
- 3005180920
- 3003236702
- 3007109793
- 3010178296
- 3011061237
- 2011171
- 2090040
- 3002808227
- 3014162916
- 3017034897
- 3025141
- 3006563559
- 1058584
- 1054811
- 3038503932
- 3025608439
- 3016948539
- 3014680795
- 1226183
- 3030926959
- 3016676864
- 1017294
- 3022393834
- 3007319107
- 3003139373
- 1043653
- 3009756327
- 3014004349
- 2183946
- 1319660
- 1835296
- 3017210488
- 3032412536
- 3003755939
- 3010692967
- 3016660811
- 1649390
- 3032314868
- 1220246
- 3014273424
- 3017196117
- 3006108336
- 3013176080
- 3010375065
- 2032098
- 3008868758
- 3009513193
- 3015542154
- 3013756169
- 3003604053
- 3021632375
- 3029312837
- 3006498370
- 3015075784
- 3014232239
Source Documents#
Other 510(k) Records For Product Code MBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-02 |
Legacy Summary#
summary
FDA Review#
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