DEVICE: STOMA® titanium bone screw (ESAM23053081)

Device Identifier (DI) Information

STOMA® titanium bone screw
23053.08
In Commercial Distribution
23053.08
Storz am Mark GmbH
ESAM23053081
HIBCC

3
318268125 *Terms of Use
STOMA® titanium bone screws Ø1,3 X 8mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. STOMA® titanium bone screws are delivered in non-sterile conditions.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46638 Craniofacial bone screw, non-bioabsorbable
A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DZL Screw, Fixation, Intraosseous
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K051871 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 8 Millimeter
Outer Diameter: 1.3 Millimeter
CLOSE

Device Record Status

5d9cf3b6-c9d3-4aef-b69e-4775f518d8ef
June 06, 2025
5
October 16, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: ESAM23053080 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
9999999999
sam@stoma.de
CLOSE