510(k) K231262
- Device
- Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
- Applicant
- Stryker GmbH
- 510(k) number
- K231262
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-18
- Date received
- 2023-05-01
- 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
- Danese Joiner-Fox
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3010123206
- 3010287687
- 3009153862
- 3003525643
- 3016851379
- 1824199
- 9615128
- 3013055499
- 3021008900
- 3010370500
- 3010158639
- 3015876273
- 3014763043
- 3015882686
- 3010400367
- 3008114965
- 3004187715
- 3026311512
- 3001239363
- 3009158523
- 3006487372
- 1218017
- 3005751028
- 3015877656
- 3013561205
- 2249615
- 3010120104
- 2953359
- 1000461041
- 3031261833
- 3013014058
- 3009971621
- 3009532798
- 3006272282
- 3009996260
- 3027760323
- 3010120339
- 3014262693
- 8043792
- 3010052483
- 3014680795
- 3005061536
- 1834331
- 3005290844
- 1058084
- 9613350
- 3009756327
- 3009973505
- 1818910
- 3014302784
- 3021226419
- 2530808
- 3020584246
- 3010329663
- 9611112
- 3004217743
- 3003322138
- 3015946784
- 3012755988
- 2320767
- 3009540749
- 3016050940
- 3010331645
- 1057946
- 3006128100
- 3007993775
- 3035785605
- 3015230955
- 3027339877
- 3009973699
- 3009144915
- 3006001176
- 9616680
- 1319429
- 9613369
- 3010123256
- 3005983700
- 3016237080
- 2028632
- 3004153896
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |