Model: 377-00-07
Catalog: 377-00-07
DI: 10885862653635
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
Scapula Reconstruction System, Offset Hook Crimper
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:
1
Record Key:
61d6913f-cf4e-421a-8d10-bafad267fe41
Distribution Status:
In Commercial Distribution
DUNS Number:
157565946
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:
10885862653635
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44795
Name: Manual orthopaedic bender, reusable
Definition:
A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.
FDA Product Codes
HRS
Plate, fixation, bone
Premarket Submissions
Submission Number:
K243275
Supplement Number:
000