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Tatum Surgical Bone Fixation Screw Kit

FDA UDI

Class II (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name
Tatum Surgical Bone Fixation Screw Kit FDA UDI
Generic Name
Craniofacial bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocks Tatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 Drill. FDA UDI
Model / Reference
E-Z bone Fixation Screw Kit FDA UDI
Description
Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocks Tatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 Drill. FDA UDI

Identifiers

Catalog Number
EZ-Bone Fixation Screw Kit FDA UDI
Primary DI / UDI-DI
00083208000003 FDA UDI
510(k) Number
K141764 FDA UDI
FDA Product Code
DZL FDA UDI
GMDN Term
Craniofacial bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Craniofacial bone screw, non-bioabsorbable, non-sterile

Tatum Surgical Bone Fixation Screw Kit by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial bone screw, non-bioabsorbable, non-sterile.

Cleared under the same submission

K141764 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suncoast Dental, Inc.

Sources (1)

  • FDA UDI 3cd90f1b-78f6-4cc7-a6b8-7356ba4cdfac 36 fields · synced May 30, 2026