510(k) K021312
- Device
- EBI DFS OPTIROM ELBOW FIXATOR
- Applicant
- EBI, L.P.
- 510(k) number
- K021312
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-23
- Date received
- 2002-04-25
- Regulation
- 888.3030
- Classification name
- Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JON CAPAROTTA
- Address
- 399 Jefferson Rd. Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3010667733
- 3014314623
- 3034676720
- 2183946
- 9710312
- 3010158639
- 3004176895
- 3005497913
- 3010390570
- 3025603301
- 3015709929
- 3006272282
- 3007993775
- 3002808145
- 1043534
- 3030966822
- 3005596372
- 3009732568
- 3012711663
- 1220246
- 3021008900
- 3011500362
- 3014273424
- 3004983210
- 1424434
- 3010303097
- 3007289093
- 2031910
- 3009201148
- 3000327445
- 2648920
- 3006001176
- 1835296
- 9681191
- 3010673850
- 3014967149
- 3002807295
- 1051526
- 3006015326
- 3003935342
- 3009116370
- 3015440604
- 3006849754
- 3031800723
- 3011683674
- 3028117759
- 3016084569
- 2090040
- 3010049501
- 3013365802
- 3011578810
- 3010502940
- 3022142628
- 3014315560
- 9610612
- 1057425
- 1834331
- 1020279
- 1835444
- 1060840
- 3013194153
- 1835831
- 3011024991
- 3006946279
- 3009746186
- 3002949614
- 3015882686
- 3008599979
- 3017168764
- 3010287687
- 3021680719
- 3043355196
- 3001239363
- 3015231789
- 3006460162
- 3015398319
- 1000517406
- 3014128887
- 3012755988
- 1818910
Source Documents#
Other 510(k) Records For Product Code KTT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | 2026-06-11 |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026-04-17 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| K253291 | Excelsior System | Blue Ocean Global | 2026-01-20 |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | 2025-11-25 |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025-11-20 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 |
| K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025-08-08 |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-05-07 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-02-21 |
| K242861 | TrueLok Elevate | Orthofix Srl | 2024-12-03 |
Legacy Summary#
summary
FDA Review#
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