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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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T-15 Driver
Zavation LLC
869-1029
In Commercial Distribution

  • 00197157007508 ()


  • Spinal fixation plate, non-bioabsorbable
Short Universal Driver, T-20
Zavation LLC
869-1023
In Commercial Distribution

  • 00197157007430 ()


  • Spinal fixation plate, non-bioabsorbable
Lock Screw Driver T-10
Zavation LLC
869-1018
In Commercial Distribution

  • 00197157007416 ()


  • Spinal fixation plate, non-bioabsorbable
Universal Driver Sleeve
Zavation LLC
869-1017
In Commercial Distribution

  • 00197157007409 ()


  • Spinal fixation plate, non-bioabsorbable
Universal Driver, T-20
Zavation LLC
869-1015
In Commercial Distribution

  • 00197157007386 ()


  • Spinal fixation plate, non-bioabsorbable
Straight Driver, T-20
Zavation LLC
869-1014
In Commercial Distribution

  • 00197157007379 ()


  • Spinal fixation plate, non-bioabsorbable
T-10 Driver (modified post)
Zavation LLC
690-1101
In Commercial Distribution

  • 00197157005900 ()


  • Spinal fixation plate, non-bioabsorbable
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
SAB-30002e
In Commercial Distribution

  • 08806109701068 ()


  • Tendon/ligament bone anchor, bioabsorbable
RFN-ADVANCED POLYMER INLAY STERILE
Synthes GmbH
08.233.001S
In Commercial Distribution

  • 10886982347572 ()
08233001S

  • Bone screw fixation sleeve
Poly Quick Driver
GS Medical Co., Ltd.
GS110-1130
In Commercial Distribution

  • 08806162199178 ()
GS110-1130

  • Polymeric spinal interbody fusion cage
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