510(k) K020221
- Device
- IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
- Applicant
- BIOMET ORTHOPEDICS, INC.
- 510(k) number
- K020221
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-04-02
- Date received
- 2002-01-22
- Regulation
- 888.3030
- Classification name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOMNIE WITHAM
- Address
- P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3009158523
- 3015978338
- 2249615
- 3002579136
- 3024813436
- 1320894
- 3011500362
- 1424434
- 3011137372
- 3016247852
- 1043534
- 3009196021
- 3013561205
- 9610921
- 3025603301
- 1528646
- 3004748528
- 3005497913
- 3013700547
- 3034676720
- 3007441485
- 3036042032
- 3014655115
- 3005874553
- 9611112
- 3006128100
- 3015869492
- 3003322138
- 3006217744
- 3004217743
- 3043026734
- 3011296511
- 3026035863
- 9680825
- 3009998573
- 1220246
- 1720929
- 1319429
- 3013365802
- 9616680
- 3010173425
- 3020584246
- 8010099
- 3016112537
- 1835251
- 3013843055
- 3010120339
- 3002808145
- 1835444
- 3016759112
- 3017191784
- 3000270450
- 3006001176
- 9615128
- 3013413393
- 3010041499
- 3010646402
- 2183967
- 3010178296
- 3010863450
- 2183785
- 3007051929
- 1835572
- 3013846070
- 1450662
- 3044753263
- 3006272282
- 3010047454
- 2647346
- 3021226419
- 3003661942
- 3003541440
- 3010118938
- 2011171
- 8043792
- 3010314800
- 3003935342
- 3005983700
- 3015806723
- 3008868758
Source Documents#
Other 510(k) Records For Product Code HRS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263602 | Arthrex Plates, Screws and Pins, and Washers | Arthrex, Inc. | 2026-10-29 |
| K261135 | Trochlear Salvage Plating System | Skeletal Dynamics, Inc. | 2026-10-26 |
| K262779 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2026-10-23 |
| K263407 | Tempo Plating System | Pace Surgical | 2026-10-23 |
| K263269 | Park's Pectus System | Tdm Co., Ltd. | 2026-10-15 |
| K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2026-10-02 |
| K262649 | Alians Forearm | Newclip Technics | 2026-09-28 |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026-09-23 |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026-09-18 |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026-09-15 |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026-09-03 |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-08-28 |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-08-19 |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | 2026-08-13 |
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 |
Legacy Summary#
summary
FDA Review#
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