FDA.report

ENDOSKELETON® Posterior DPK

Primary DI
00191375010265
Brand
ENDOSKELETON® Posterior DPK
Company
TITAN SPINE, LLC
Model
1100-0017
Catalog number
1100-0017
Device description
Kerrison Rongeur, 3mm, 8in Long
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191375010265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191375010265001913750102651913750102650191375010265

GMDN Terms

TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(262)242-7801productinfo@titanspine.com

Regulatory Flags

DUNS number
623316978
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M682230013150ENDOSKELETON® TAS2300-13152300-13152017-01-03
M682420001130ENDOSKELETON®4200-01134200-01132017-01-19
M682521010620ENDOSKELETON TCS5210-10625210-10622016-12-13
M682521010630ENDOSKELETON TCS5210-10635210-10632016-12-13
M682521010640ENDOSKELETON TCS5210-10645210-10642016-12-13
M682521010650ENDOSKELETON TCS5210-10655210-10652016-12-13
M682521010660ENDOSKELETON TCS5210-10665210-10662016-12-13
M682490010220ENDOSKELETON TT4900-10224900-10222016-12-08
M682790010080ENDOSKELETON TL7900-10087900-10082016-10-06
M682110000130ENDOSKELETON Posterior DPK1100-00131100-00132016-09-17
M682110000170ENDOSKELETON Posterior DPK1100-00171100-00172016-09-17
M682110000180ENDOSKELETON Posterior DPK1100-00181100-00182016-09-17
M682110000190ENDOSKELETON Posterior DPK1100-00191100-00192016-09-17
M682110000200ENDOSKELETON Posterior DPK1100-00201100-00202016-09-17
M682110000210ENDOSKELETON Posterior DPK1100-00211100-00212016-09-17
M682110000220ENDOSKELETON Posterior DPK1100-00221100-00222016-09-17
M682110000230ENDOSKELETON Posterior DPK1100-00231100-00232016-09-17
M682110000240ENDOSKELETON Anterior DPK1100-00241100-00242016-09-17
M682110000250ENDOSKELETON Posterior DPK1100-00251100-00252016-09-17
M682113010100ENDOSKELETON Sterile Barrier System1130-10101130-10102016-09-17

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