510(k) K113364
- Device
- 2.7MM LCP ULNA OSTEOTOMY SYSTEM
- Applicant
- SYNTHES (USA) PRODUCTS LLC
- 510(k) number
- K113364
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-02-29
- Date received
- 2011-11-15
- 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
- REBECCA BLANK
- Address
- 1230 Wilson Dr. West Chester PA US 19380 19380
FDA Registration Numbers#
- 2183449
- 3012491394
- 2183946
- 3010123172
- 3009973699
- 3009760038
- 1058084
- 3012470322
- 1834379
- 1833506
- 3035785605
- 3014262693
- 9612277
- 3012818475
- 3030714745
- 1526534
- 3009971621
- 3010400367
- 1030489
- 3004464325
- 3038503572
- 3008868758
- 8010177
- 3007113169
- 3013846070
- 3003541440
- 3013561205
- 3010120104
- 3016727307
- 3022777867
- 3015882686
- 3014315669
- 3012478585
- 3016050940
- 3019807891
- 3010047402
- 1051526
- 1220477
- 1835444
- 3010039400
- 2183967
- 9680825
- 3008285983
- 3012447612
- 3009513193
- 2028523
- 3004549189
- 3007334927
- 3016778139
- 1828288
- 3009201148
- 3003322138
- 2648666
- 3015869121
- 3010197224
- 3008658204
- 1450662
- 3017980495
- 3016237080
- 1226425
- 9611278
- 3009144915
- 2030624
- 3003661942
- 3002808145
- 3011301313
- 9610612
- 3034676720
- 3019767615
- 3010047454
- 3017191784
- 3004635447
- 3013011598
- 3009189869
- 3019269298
- 3009381600
- 3004371426
- 3004976965
- 1833824
- 3010120326
Source Documents#
Other 510(k) Records For Product Code HRS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | 2026-07-16 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | 2026-06-16 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026-06-12 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 |
Legacy Summary#
summary
FDA Review#
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