510(k) K203634
- Device
- BioPoly Great Toe Hemiarthroplasty Implant
- Applicant
- BioPoly, LLC
- 510(k) number
- K203634
- Product code
- KWD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-02
- Date received
- 2020-12-11
- Regulation
- 888.3730
- Classification name
- Prosthesis, Toe, Hemi-, Phalangeal
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Herb Schwartz
- Address
- 7136 Gettysburg Pike Fort Wayne IN US 46804 46804
FDA Registration Numbers#
- 3007193505
- 1220246
- 3010531069
- 2183744
- 2029275
- 3014833750
- 2027754
- 1220477
- 2244478
- 3009826895
- 3003477135
- 3002579136
- 1054811
- 3015974593
- 3004499989
- 8010257
- 3010667733
- 2530808
- 3020650900
- 3008108789
- 3016851379
- 3006017180
- 3019269298
- 2183946
- 3010400367
- 1226544
- 3009423112
- 3015151147
- 3014004349
- 1833506
- 2032521
- 3011277306
- 1649518
- 3017486146
- 1043534
- 1051526
- 3009513193
- 1043653
- 3004154314
- 3009923578
- 3014207283
- 1225967
- 2245304
- 3005497913
- 1526534
- 1222928
- 3015916578
- 3007420745
Source Documents#
Other 510(k) Records For Product Code KWD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | 2026-04-03 |
| K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2024-02-29 |
| K221220 | Montross Extremity Medical Hemi Implant System | Montross Extremity Medical | 2023-04-19 |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022-11-22 |
| K201393 | restor3d MTP Implant | Restor3D, Inc. | 2022-05-25 |
| K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2020-12-08 |
| K190261 | BOSS Toe Fixation System | Arthrosurface, Inc. | 2019-08-14 |
| K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019-05-31 |
| K161279 | Life Spine Metatarsal Hemi Implant | Life Spine, Inc. | 2017-02-01 |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016-04-11 |
| K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | 2013-11-19 |
| K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | Solana Surgical, LLC | 2013-10-22 |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | Biopro, Inc. | 2012-10-30 |
| K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 |
| K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 |
Legacy Summary#
summary
FDA Review#
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