Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SCEW GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X0300019
In Commercial Distribution

  • 00673978995656 ()


  • General internal orthopaedic fixation system implantation kit
10mm 22cm Claw Grasper, 2x3 teeth, single action, 3-piece modular scew-apart, type 10 handle: lightweight carbon-fiber with large front finger, RF post & ratchet
Avalign Technologies, Inc.
72-5210236C10M22
In Commercial Distribution

  • 00190776387495 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
EC LONG TRANSFER SCERW
SOADCO, S.L.
10 09 04.2 L
In Commercial Distribution

  • 08435451601261 ()
10 09 04.2 L

  • Dental implant suprastructure kit
MONARCH SPINE SYSTEM NO CUT SCEW CADDIE 8.50mm
DEPUY SPINE, LLC
277091850
Not in Commercial Distribution

  • 10705034197296 ()
277091850

  • Instrument tray, reusable
MONARCH SPINE SYSTEM NO CUT SCEW CADDIE 7.75mm
DEPUY SPINE, LLC
277091775
Not in Commercial Distribution

  • 10705034197289 ()
277091775

  • Instrument tray, reusable
MONARCH SPINE SYSTEM NO CUT SCEW CADDIE 5.50mm
DEPUY SPINE, LLC
277091550
Not in Commercial Distribution

  • 10705034197272 ()
277091550

  • Instrument tray, reusable
MONARCH SPINE SYSTEM NO CUT SCEW CADDIE 4.75mm
DEPUY SPINE, LLC
277091475
Not in Commercial Distribution

  • 10705034197265 ()
277091475

  • Instrument tray, reusable
Scewdriver Shaft
SPINAL ELEMENTS
TL2211
In Commercial Distribution

  • 00840916135157 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Extended Tab Scerw Persuader
GS Medical Co., Ltd.
GS114-0760
In Commercial Distribution

  • 08806395498079 ()
GS114-0760

  • Orthopaedic counter-torque/rod-pushing instrument
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-314
In Commercial Distribution

  • 18859751213141 ()
  • 08859751213144 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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