201508

GUDID H9802015080

2.4MM CORTEX SCREW SELF-TAPPING 8MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Primary Device ID	H9802015080
NIH Device Record Key	a8d552a8-05d9-4393-9415-6e06d99cab91
Commercial Distribution Status	In Commercial Distribution
Version Model Number	201.508
Catalog Number	201508
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587028538 [Primary]
HIBCC	H9802015080 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K964261

FDA Product Code

DZL	SCREW, FIXATION, INTRAOSSEOUS

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

H981PDL432F - NA	2026-02-09 INLAY PUSHER-MEDIUM
H981PDL434H - NA	2026-02-09 INLAY PUSHER-LARGE
07611819995796 - NA	2026-02-09 TAMP
07611819943490 - NA	2026-02-09 HEAD IMPACTOR
H679E51157P09 - NA	2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR
10886982293060 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
10886982293237 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25

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