FDA.report

Sternal fixation device

Definition
A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.
GUDID devices
790
Last updated
2026-03-03 20:37:05

Related Product Codes

CodeDeviceSpecialtyClassDevices
HRSPlate, Fixation, BoneOrthopedic2412
HWCScrew, Fixation, BoneOrthopedic2255
JDQCerclage, FixationOrthopedic287
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology214
LXHOrthopedic Manual Surgical InstrumentOrthopedic19
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery14
HXXScrewdriverOrthopedic13
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery12
HTWBit, DrillOrthopedic11
HWTTemplateOrthopedic11
JEYPlate, BoneDental21
LRPTray, SurgicalGeneral, Plastic Surgery11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00888118146656LEVEL ONEKLS-Martin L.P.24-010-07-072026-02-23
00888118146663LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-07-712025-08-26
00888118146670LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-42-712025-08-26
00888118146687LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-43-712025-08-26
00888118146694LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-44-712025-08-26
00888118146700LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-45-712025-08-26
00888118146717LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-46-712025-08-26
00888118146724LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-47-712025-08-26
00888118146731LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-48-712025-08-26
00888118146748LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-49-712025-08-26
00888118146755LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-50-712025-08-26
00888118146762LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-51-712025-08-26
00888118146779LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-52-712025-08-26
00888118146786LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-54-712025-08-26
00888118146793LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-55-712025-08-26
00888118146809LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-56-712025-08-26
00888118146816LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-57-712025-08-26
00888118146823LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-58-712025-08-26
00888118146830LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-59-712025-08-26
00888118146847LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-60-712025-08-26
00888118146854LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-61-712025-08-26
00888118146861LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-62-712025-08-26
00888118146878LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-025-63-712025-08-26
00888118146649LEVEL ONEKLS-Martin L.P.SP-2024-00012025-06-23
00888118143204LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-010-43-712025-04-22
00888118143211LEVEL ONE THORACIC, STERILEKLS-Martin L.P.24-010-44-712025-04-22
10841291105794Sternal Cable SystemA & E MEDICAL CORPORATION400-4012025-04-21
10841291105817Sternal Cable SystemA & E MEDICAL CORPORATION400-4102025-04-21
10841291105824Sternal Cable SystemA & E MEDICAL CORPORATION400-4112025-04-21
10841291105831Sternal Cable SystemA & E MEDICAL CORPORATION400-4132025-04-21
10841291105855Sternal Cable SystemA & E MEDICAL CORPORATION400-4252025-04-21
10841291105862Sternal Cable SystemA & E MEDICAL CORPORATION400-4272025-04-21
10841291105893Sternal Cable SystemA & E MEDICAL CORPORATION400-6892025-04-21
10841291105909Sternal Cable SystemA & E MEDICAL CORPORATION400-6902025-04-21
10841291105916Sternal Cable SystemA & E MEDICAL CORPORATION400-7272025-04-21
10841291105923Sternal Cable SystemA & E MEDICAL CORPORATION400-8902025-04-21
10841291105930Sternal Cable SystemA & E MEDICAL CORPORATION401-0202025-04-21
10841291105947Sternal Cable SystemA & E MEDICAL CORPORATION401-0962025-04-21
10841291105954Sternal Cable SystemA & E MEDICAL CORPORATION402-5222025-04-21
10841291105961Sternal Cable SystemA & E MEDICAL CORPORATION402-5232025-04-21
10841291105978Sternal Cable SystemA & E MEDICAL CORPORATION402-6182025-04-21
10841291105992Sternal Cable SystemA & E MEDICAL CORPORATION407-7142025-04-21
10841291106005Sternal Cable SystemA & E MEDICAL CORPORATION408-7192025-04-21
10841291106012Sternal Cable SystemA & E MEDICAL CORPORATION408-7202025-04-21
10841291106029Sternal Cable SystemA & E MEDICAL CORPORATION408-7212025-04-21
10841291106036Sternal Cable SystemA & E MEDICAL CORPORATION408-7222025-04-21
10841291106043Sternal Cable SystemA & E MEDICAL CORPORATION408-7232025-04-21
10841291106081Sternal Cable SystemA & E MEDICAL CORPORATION431-7622025-04-21
07613327401523NAStryker Leibinger GmbH & Co. KG47400132025-01-09
07613327401554NAStryker Leibinger GmbH & Co. KG47400152025-01-09
07613327401561NAStryker Leibinger GmbH & Co. KG47400142025-01-09
07613327401738NAStryker Leibinger GmbH & Co. KG47400162025-01-09
28437006085452STERN FIXNEOS SURGERY SLSC0102222024-09-04
28437006085469STERN FIXNEOS SURGERY SLSC0103332024-09-04
08437006085472STERN FIXNEOS SURGERY SLSC0104442024-09-04
28437006085483STERN FIXNEOS SURGERY SLSC0105552024-09-04
28437006085445STERN FIXNEOS SURGERY SLSC0101112024-09-01
07899258661872Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAQuadrilateral Versalock Sternum Tape Plate - 04 Ho2024-07-12
07899258661889Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAQuadrilateral Versalock Sternum Plate - 04 Holes2024-07-12
07899258661896Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDASternum Fixation Versa Plate - 04 Holes2024-07-12
07899258661902Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDASternum Fixation Versa Plate - 08 Holes2024-07-12
07899258662428Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAVersalock Sternum Plate - 100° - 04 Holes2024-07-12
07899258662435Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“H” Versalock Sternum Plate - 08 Holes2024-07-12
07899258662442Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDADouble Quadrilateral Wide Versalock Sternum Plate 2024-07-12
07899258662459Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDADouble Quadrilateral Narrow Versalock Sternum Plat2024-07-12
07899258662473Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“JL” Versalock Sternum Plate - 08 Holes2024-07-12
07899258662480Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“Butterfly” Versalock Sternum Tape Plate - 06 Hole2024-07-12
07899258662497Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“H” Versalock Sternum Tape Plate - 08 Holes2024-07-12
07899258663012Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“T” Versalock Sternum and Rib Plate - 40 Holes2024-07-12
07899258663098Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAVersalock Sternum Plate - 100° - 04 Holes2024-07-12
07899258663104Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAQuadrilateral Versalock Sternum Plate - 04 Holes2024-07-12
07899258663111Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“H” Versalock Sternum Plate - 08 Holes2024-07-12
07899258663128Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“JL” Versalock Sternum Plate - 08 Holes2024-07-12
07899258663135Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDADouble Quadrilateral Wide Versalock Sternum Plate 2024-07-12
07899258663142Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDADouble Quadrilateral Narrow Versalock Sternum Plat2024-07-12
07899258663159Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDASternum Fixation Versa Plate - 04 Holes2024-07-12
07899258663166Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDASternum Fixation Versa Plate - 08 Holes2024-07-12
07899258663173Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“H” Versalock Sternum Tape Plate - 08 Holes2024-07-12
07899258663180Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAQuadrilateral Versalock Sternum Tape Plate - 04 Ho2024-07-12
07899258663197Versalock Rib and Sternum Plates SystemGM DOS REIS INDUSTRIA E COMERCIO LTDA“Butterfly” Versalock Sternum Tape Plate - 06 Hole2024-07-12