510(k) K011458
- Device
- SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
- Applicant
- SYNTHES (USA)
- 510(k) number
- K011458
- Product code
- KTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-02
- Date received
- 2001-05-11
- Regulation
- 888.3030
- Classification name
- Appliance, Fixation, Nail/blade/plate Combination, Single Component
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATTHEW M HULL
- Address
- P.O. Box 1766 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 8043792
- 3000270450
- 3011302692
- 3015869121
- 1220246
- 1000547811
- 3015869493
- 3012329552
- 3009350690
- 2011171
- 3004983210
- 9680825
- 1825034
- 3004464325
- 3013176080
- 3015440604
- 3014128887
- 3015207155
- 3034676720
- 2183449
- 3015869492
- 3015212339
- 2029275
- 3008868758
- 1526439
- 3029933740
- 3002808145
- 3035366890
- 8010916
- 3009417901
- 2032112
- 3008812560
- 3006694268
- 3015882686
- 1043653
- 1526534
- 2090040
- 3010123256
- 3008534770
- 3016084569
- 3009973336
- 3004049923
- 1649390
- 3015399803
- 3010303097
- 3007887127
- 8031020
- 3006272282
- 3008650117
Source Documents#
Other 510(k) Records For Product Code KTW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | 2019-06-20 |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-06-22 |
| K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017-06-19 |
| K160409 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2016-03-15 |
| K122541 | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | Orthofix Srl | 2012-09-20 |
| K080590 | AOS PROXIMAL HUMERAL PLATE | Advanced Orthopaedic Solutions, Inc. | 2008-05-06 |
| K080109 | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM | Synthes (Usa) | 2008-03-20 |
| K062920 | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | Orthofix Srl | 2006-11-13 |
| K023360 | LEFORTE SYSTEM BONE PLATE | Jeil Medical Corporation | 2002-10-25 |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Alliance Medical, Inc. | 2002-06-24 |
| K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2002-06-24 |
| K011815 | SYNTHES LCP PROXIMAL HUMERUS PLATES | Synthes (Usa) | 2001-09-06 |
| K010321 | MODULAR FOOT SYSTEM - 2.7 MM MODULE | Synthes (Usa) | 2001-05-02 |
| K001614 | STRYKER TRAUMA PELVIC SET | Howmedica Osteonics Corp. | 2000-08-04 |
| K001271 | SAMARCO SPIDER PLATES | Biomet, Inc. | 2000-07-14 |
Legacy Summary#
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FDA Review#
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