Identity
- Trade Name
- TS-Bone Hip Plate FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- 140° Titanium TS-Bone Hip Plate FDA UDI
- Model / Reference
- PDT-140 FDA UDI
- Description
- 140° Titanium TS-Bone Hip Plate FDA UDI
Identifiers
- Catalog Number
- PDT-140 FDA UDI
- Primary DI / UDI-DI
- 00813892020038 FDA UDI
- 510(k) Number
- K063709 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Dimensions & Sizes
- Size
- Angle — 140 degree FDA UDI
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
TS-Bone Hip Plate by Orthopedic Sciences, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.
- ACUMED — ACUMED LLC · Class II
- AlignMate — ARTHROSURFACE INCORPORATED · Class II
- ACUMED — ACUMED LLC · Class II
- NCB® — Zimmer, Inc. · Class II
- ACUMED — ACUMED LLC · Class II
- NCB® — Zimmer, Inc. · Class II
- NCB® — Zimmer, Inc. · Class II
- ACUMED — ACUMED LLC · Class II
Cleared under the same submission
K063709 also covers:
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
- TS-Bone Hip Plate — ORTHOPEDIC SCIENCES, INC
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
- Orthopedic Sciences, Inc
Sources (1)
- FDA UDI 3a2c441d-c9ed-4eec-aee7-6d1a6c6fecac 38 fields · synced Jun 1, 2026