Identity
- Trade Name
- Pin Puller FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Model / Reference
- 109565 FDA UDI
Identifiers
- Catalog Number
- 109565 FDA UDI
- Primary DI / UDI-DI
- M9461095650 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Joint prosthesis implantation kit, reusable
Pin Puller by Think Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Joint prosthesis implantation kit, reusable.
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- IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
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- GUARDIAN® — MicroPort Orthopedics Inc. · Class I
- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- PROPHECY — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K230202 also covers:
- Angel Wing — Think Surgical Inc.
- Array Guide — Think Surgical Inc.
- CT Motion Rod, 42 inch — Think Surgical Inc.
- CT Motion Rod, 54 inch — Think Surgical Inc.
- Digitizer — Think Surgical Inc.
- Femur Tracking Array — Think Surgical Inc.
- Square Driver — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Medacta® Knee System — Think Surgical Inc.
K232802 also covers:
- Angel Wing — Think Surgical Inc.
- Array Guide — Think Surgical Inc.
- CT Motion Rod, 42 inch — Think Surgical Inc.
- CT Motion Rod, 54 inch — Think Surgical Inc.
- Digitizer — Think Surgical Inc.
- Femur Tracking Array — Think Surgical Inc.
- Square Driver — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Medacta® Knee System — Think Surgical Inc.
K241031 also covers:
- Angel Wing — Think Surgical Inc.
- Array Guide — Think Surgical Inc.
- CT Motion Rod, 42 inch — Think Surgical Inc.
- CT Motion Rod, 54 inch — Think Surgical Inc.
- Digitizer — Think Surgical Inc.
- Femur Tracking Array — Think Surgical Inc.
- Square Driver — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Medacta® Knee System — Think Surgical 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Think Surgical Inc.
Sources (1)
- FDA UDI acb36c18-2edc-496d-87af-dbf72ae1fd49 35 fields · synced Jun 8, 2026