CA4000068

GUDID 00841379102717

ACP, 4 LEVEL, 68MM

HYHTE HOLDINGS, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00841379102717
NIH Device Record Keyffc8d487-4238-4b41-8270-336bdcef09a7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCA4000068
Catalog NumberCA4000068
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
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0
Length68 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379102717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

[00841379102717]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085254413 - NA2024-05-07 POLYAXIAL, TULIP
00840085254420 - NA2024-05-07 POLYAXIAL, HIGH TOP, TULIP
00840085254437 - NA2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
00840085254444 - NA2024-05-07 FAVORED ANGLE M/L, TULIP
00840085254451 - NA2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
00840085254468 - NA2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
00840085254475 - NA2024-05-07 FAVORED ANGLE C/C, TULIP
00840085254482 - NA2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.