FDA.reportPublic FDA data

RESPONSE 5.5/6.0 SPINE SYSTEM

Primary DI
00841132139745
Brand
RESPONSE 5.5/6.0 SPINE SYSTEM
Company
ORTHOPEDIATRICS CORP.
Model
00-1300-0970
Catalog number
00-1300-0970
Device description
5.5/6.0 UNIAXIAL PEDICLE SCREWS -Ø9MM x 70MM LENGTH
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132139745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132139745008411321397458411321397450841132139745

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379bsmith@orthopediatric.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13
00841132199312OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6014-S00-1200-6014-S2026-05-13
00841132199329OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6015-S00-1200-6015-S2026-05-13

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07613153045670XIA IStryker CorporationKWP2014-12-08
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07613153045700XIA IStryker CorporationKWP2014-12-08
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07613153045717XIA IStryker CorporationKWP2014-12-08
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07613153045724XIA IStryker CorporationNKB2014-12-08
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07613153045748XIA IStryker CorporationNKB2014-12-08
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07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationNKB2014-12-08
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07613153045847XIA IIStryker CorporationNKB2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationNKB2014-12-08
07613153045861XIA IIStryker CorporationNKB2014-12-08
07613153045861XIA IIStryker CorporationKWP2014-12-08
07613153045878XIA IIStryker CorporationKWP2014-12-08
07613153045885XIA IIStryker CorporationKWP2014-12-08
07613153045885XIA IIStryker CorporationNKB2014-12-08
07613153045892XIA IIStryker CorporationNKB2014-12-08
07613153045892XIA IIStryker CorporationKWP2014-12-08