FDA.report

APEX-DL Spine System

Primary DI
00193082152153
Brand
APEX-DL Spine System
Company
SPINECRAFT, LLC
Model
DPF6-8555-XL
Catalog number
DPF6-8555-XL
Device description
APEX-DL X-Large Polyaxial Screw Dia. 8.50 x 55mm, Self-tapping
Published
2020-11-10
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
true

Related Records

Contact Domains

Product Codes

CodeName
NKBThoracolumbosacral pedicle screw system

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00193082152153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082152153001930821521531930821521530193082152153

GMDN Terms

TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(630)920-7300info@spinecraft.com

Regulatory Flags

DUNS number
783908713
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
true

Other Devices From This Company

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00193082163173ASTRA-OCT Spine System6600-T15-3L6600-T15-3L2025-03-17
00193082163180ORIO7020-02-08B7020-02-08B2025-01-30
00193082163197ORIO7020-02-10B7020-02-10B2025-01-30
00193082163203ORIO7020-02-12B7020-02-12B2025-01-30
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00193082155918APEX Spine System6000-14-L46000-14-L42024-11-08
00193082155925APEX Spine System6000-14-R46000-14-R42024-11-08
00193082155932ASTRA-OCT Spine System6600-8506600-8502024-11-08
00193082156700ASTRA Spine SystemA6L-OTL150A6L-OTL1502024-11-08
00193082156717ASTRA Spine SystemA6L-OT015A6L-OT0152024-11-08
00193082156724ASTRA Spine SystemA6L-OT150A6L-OT1502024-11-08
00193082163029ASTRA Spine System6300-89C-PSN6300-89C-PSN2024-11-08
00193082163050ASTRA Spine System6300-97-R6300-97-R2024-11-08
00193082163067APEX Spine SystemF6-1837F6-18372024-11-08
00193082163074APEX Spine SystemF6-1834F6-18342024-11-08
00193082163081APEX Spine SystemF6-1831F6-18312024-11-08
00193082163098ASTRA Spine SystemA5D-C4A5D-C42024-11-08

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