Identity
- Trade Name
- PANTERA PLATE, LEFT, 160mm FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- NA FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- TO-PHP-L160 FDA UDI
- Primary DI / UDI-DI
- 00816101010950 FDA UDI
- 510(k) Number
- K081608 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
PANTERA PLATE, LEFT, 160mm by Toby Orthopaedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081608 also covers:
- 2.0mm Cross Element, 25mm — TOBY ORTHOPAEDICS
- 2.0mm Cross Element, 30mm — TOBY ORTHOPAEDICS
- 2.0mm Cross Element, 35mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 10mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 12mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 14mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 16mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 18mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 20mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 22mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 28mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 30mm — TOBY ORTHOPAEDICS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Toby Orthopaedics
Sources (1)
- FDA UDI 47638681-33e0-4a41-b342-0417c243aea1 36 fields · synced May 30, 2026