DEVICE: Baby Gorilla/Gorilla Plating System (00889795051233)

Device Identifier (DI) Information

Baby Gorilla/Gorilla Plating System
P50-553-5248
In Commercial Distribution
P50-553-5248
PARAGON 28, INC.
00889795051233
GS1

1
042961576 *Terms of Use
SILVERBACK Locking Plate Screw, 5.2 x 48mm
CLOSE

Device Characteristics

MR Unsafe
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?
56642 Orthopaedic bone screw, non-bioabsorbable, non-sterile
A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HWC Screw, fixation, bone
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K190365 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
No Device Sizes
CLOSE

Device Record Status

eee14943-3b47-4b78-9a56-22153cb748ef
February 19, 2024
2
October 17, 2019
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)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE