FDA.reportPublic FDA data

ENDOSKELETON® Posterior DPK

Primary DI
00191375010210
Brand
ENDOSKELETON® Posterior DPK
Company
TITAN SPINE, LLC
Model
1100-0012
Catalog number
1100-0012
Device description
Straight, Up, Bayonet, Cup Curette, Large
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCURETTE
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191375010210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191375010210001913750102101913750102100191375010210

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(262)242-7801productinfo@titanspine.com
+1(800)633-8766Corporate.UDI@medtronic.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 DI, Brand, Model table
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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