Model: 6497-2-040
Catalog: 6497-2-040
DI: 07613327659528
Status: Update
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-13
Description
LATERAL NPCP, R
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
d4bd0737-d193-45d5-9907-e625dc5a55a6
Distribution Status:
In Commercial Distribution
DUNS Number:
481999654
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07613327659528
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46647
Name: Orthopaedic fixation plate, non-bioabsorbable
Definition:
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
FDA Product Codes
HRS
Plate, fixation, bone
Premarket Submissions
Submission Number:
K253640
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
200.0
Item #1 - Size Type:
Length
Item #2 - Size Text:
Side: RIGHT
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Thickness: 5.0 Millimeter
Item #3 - Size Type:
Device Size Text, specify