DEVICE: Acme (ZB200001000)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Acme
CAT0003
In Commercial Distribution
CAT0003
Zimmer, Inc.
ZB200001000
HIBCC

2
056038268 *Terms of Use
AS2 Test Template Scenario1
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
No
Yes
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?
46653 Spinal fixation plate, non-bioabsorbable
A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
IRT PAD, HEATING, POWERED
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Chlorine Dioxide
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 101 and 1001 Inches of Mercury
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 5.5 Feet
CLOSE

Device Record Status
a16127c1-69f2-4050-821f-ec8430d4dc8d
June 18, 2025
1
June 10, 2025
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: Z0000000001 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE