Gramedica HYP-05 HyProCure Size 05

Burr, Oval, 10 flute, 3.0mm

The NeoCoil 3.OT 8-Channel Shoulder Array Coil is a multi-element phased arrayreceive only coil used for obtaining diagnostic images of the shoulder in MagneticResonance Imaging Systems. Compared to predicate devices, the submitteddevice offers easier patient setup and greater SNR due to its compatibility with3.OT MRI scanners.The submitted device consists of semi-flexible foam covered housing, consistingof eight antennas. The antennas are uniquely positioned with the appropriateoverlap to cancel out mutual coupling effects from adjacent antennas ordecoupled from an adjacent antenna using a transformer. Pre-amplifierdecoupling reduces any remaining decoupling between the antennas.The coil is held in place over the imaging area via a cross body strap. A systeminterface cable connects to the coil at the top of the housing. The flexible foamcovered housing along with the body strap enable the proper positioning on thepatient before laying down and holds the coil in place while scanning is beingperformed.To ensure safety, each antenna is equipped with active and passive transmitdecoupling circuits. Active decoupling is achieved via diodes that receive signalsfrom the scanner to turn the coil to a high impedance state during system RFtransmit. Crossed diodes are installed on each antenna acting as passiveswitches. These passive switches provide additional safety in case the activecircuitry does not receive signal from the scanner.

Mini QUICKANCHOR Plus (Number 2/0 Suture) Size 2/0 (3 metric) ORTHOCORD braided composite suture, 18 Inches (45cm), double-armed V-5 needles and 2.0 x 9.7mm drill bit, with disposable inserter.

Mini QUICKANCHOR Plus (Number 0 Suture) Size Number 0 (3 metric) ORTHOCORD braided composite suture, 36 Inches (90cm), double-armed OS-2 reverse cutting needles and 2.0 x 9.7mm drill bit, with disposable inserter.

SPEEDSCREW 5.5 MM IMPLANT

VERSALOK ANCHOR w/ORTHOCORD PEEK & Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)

FHL Implant System, 6.25 mm

MICRO QUICKANCHOR Plus (Number 4/0) Suture 4/0 (1.5 metric) white ETHIBOND braided polyester suture, with P-3 precision point needles and a 1.3 x 5.0mm drill bit

Burr, Oval, 10 flute, 3.0mm

The NeoCoil 3.OT 8-Channel Shoulder Array Coil is a multi-element phased arrayreceive only coil used for obtaining diagnostic images of the shoulder in MagneticResonance Imaging Systems. Compared to predicate devices, the submitteddevice offers easier patient setup and greater SNR due to its compatibility with3.OT MRI scanners.The submitted device consists of semi-flexible foam covered housing, consistingof eight antennas. The antennas are uniquely positioned with the appropriateoverlap to cancel out mutual coupling effects from adjacent antennas ordecoupled from an adjacent antenna using a transformer. Pre-amplifierdecoupling reduces any remaining decoupling between the antennas.The coil is held in place over the imaging area via a cross body strap. A systeminterface cable connects to the coil at the top of the housing. The flexible foamcovered housing along with the body strap enable the proper positioning on thepatient before laying down and holds the coil in place while scanning is beingperformed.To ensure safety, each antenna is equipped with active and passive transmitdecoupling circuits. Active decoupling is achieved via diodes that receive signalsfrom the scanner to turn the coil to a high impedance state during system RFtransmit. Crossed diodes are installed on each antenna acting as passiveswitches. These passive switches provide additional safety in case the activecircuitry does not receive signal from the scanner.