AccessGUDID - DEVICE: osteo-WEDGE 3.0mm x 20mm Locking Bone Screw (M621OW30LBS20MM0)

GUDID

Device Identifier (DI) Information

Brand Name: osteo-WEDGE 3.0mm x 20mm Locking Bone Screw
Version or Model: GM-500-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OW3.0LBS-20MM
Company Name: Gramedica

Primary DI Number: M621OW30LBS20MM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828660345 *Terms of Use

Device Description: osteo-WEDGE 3.0mm x 20mm Locking Bone Screw. For use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46647	Orthopaedic fixation plate, non-bioabsorbable	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. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone
HRS	Plate, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111326	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3.0mm x 20mm

Device Record Status

Public Device Record Key: c43da032-0ee7-40d8-af3b-c22b2ce5d1a3
Public Version Date: September 11, 2024
Public Version Number: 7
DI Record Publish Date: February 14, 2017