FDA UDI
In Commercial Distribution
🇺🇸 United States
PANTERA PLATE, RIGHT, 160mm
DI: 00816101010943
·
Model: NA
·
TOBY ORTHOPAEDICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PANTERA PLATE, RIGHT, 160mm
- Primary DI
- 00816101010943
- Version / Model
- NA
- Catalog Number
- TO-PHP-R160
- Company Name
- TOBY ORTHOPAEDICS
- Labeler DUNS
- 024163331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 4
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 71ecc4fa-d8e9-473a-9b55-6e661d5acef9
Device Description
The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816101010943 | GS1 |
Customer Contacts
- Phone
- 305-665-8699
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081608 | 000 |