FABA40042

GUDID 00841379141624

POLYAXIAL SCREW #1, HIGH TOP

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID00841379141624
NIH Device Record Key3f9e0827-857c-463c-99bb-3a167b3e5a1f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberFABA40042
Catalog NumberFABA40042
Company DUNS073029645
Company NameHYHTE HOLDINGS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Dimensions

Width4 Millimeter
Length42 Millimeter
Width4 Millimeter
Length42 Millimeter
Width4 Millimeter
Length42 Millimeter
Width4 Millimeter
Length42 Millimeter
Width4 Millimeter
Length42 Millimeter
Width4 Millimeter
Length42 Millimeter
Width4 Millimeter
Length42 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379141624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior Cervical Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379141624]

Moist Heat or Steam Sterilization


[00841379141624]

Moist Heat or Steam Sterilization


[00841379141624]

Moist Heat or Steam Sterilization


[00841379141624]

Moist Heat or Steam Sterilization


[00841379141624]

Moist Heat or Steam Sterilization


[00841379141624]

Moist Heat or Steam Sterilization


[00841379141624]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-27
Device Publish Date2021-07-19

Devices Manufactured by HYHTE HOLDINGS, INC.

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00840085201851 - NA2021-08-11 AXIAL HANDLE, ML, ADV 1/4 SQ, FIXED, ALUMINUM CORE, EXTERNAL, CANNULATED, SIDE LOADING SLAP CAP
00840085201882 - NA2021-08-11 T-HANDLE, L, ADV 1/4 SQ, FIXED, ALUMINUM CORE, EXTERNAL, NON-CANNULATED, S/L SLAP HAMMER CAP
00840085201899 - NA2021-08-11 T-HANDLE, L, ADV 1/4 SQ, FIXED, ALUMINUM CORE, EXTERNAL, CANNULATED, S/L SLAP HAMMER CAP
00840085214424 - NA2021-08-11 BALL TIP PROBE, 90°
00840085214431 - NA2021-08-11 PENFIELD, #4
00840085214448 - NA2021-08-11 LEXCEL RONGEUR, SERRATED
00840085214530 - NA2021-08-11 PITUITARY, STRAIGHT #4, SERRATED

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