DEVICE: Ascential ACP 1 (07613327122312)

Device Identifier (DI) Information

Ascential ACP 1
48804912A
In Commercial Distribution
48804912A
Stryker Corporation
07613327122312
GS1

1
149183167 *Terms of Use
Variable Angle Self-Tapping Screw Set
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Spinal fixation plate, non-bioabsorbable A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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).
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150700 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Length: 12.0 Millimeter
Device Size Text, specify: Diameter: 4.5 Millimeter
CLOSE

Device Record Status

d9065ec8-3036-4b36-87c4-ad7c69434444
July 06, 2018
3
September 14, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE