FDA.report

APEX Spine System

Primary DI
00193082155239
Brand
APEX Spine System
Company
SPINECRAFT, LLC
Model
6000-89-H
Catalog number
6000-89-H
Device description
Polyaxial Screwdriver
Published
2021-10-11
Public version status
New
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00193082155239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082155239001930821552391930821552390193082155239

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

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
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00193082163166ASTRA-OCT Spine System6600-01L6600-01L2025-03-17
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
00193082155888ASTRA Spine System6300-966300-962024-11-08
00193082155895APEX Spine System6000-14-L36000-14-L32024-11-08
00193082155901APEX Spine System6000-14-R36000-14-R32024-11-08
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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