Identity
- Trade Name
- GPS FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- External Tracker Fixator 30 Deg FDA UDI
- Model / Reference
- 02-521-90-0030 FDA UDI
- Description
- External Tracker Fixator 30 Deg FDA UDI
Identifiers
- Catalog Number
- 02-521-90-0030 FDA UDI
- Primary DI / UDI-DI
- 10885862564825 FDA UDI
- FDA Product Code
- HAW FDA UDIOLO FDA UDI
- GMDN Term
- Orthopaedic stereotactic surgery system 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
Dimensions & Sizes
- Size
- Angle — 30 degree FDA UDI
Category: Orthopaedic stereotactic surgery system
Gps by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic stereotactic surgery system.
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Cleared under the same submission
K100742 also covers:
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- GPS — Exactech, Inc.
- GPS — Exactech, Inc.
- GPS — Exactech, Inc.
- GPS — Exactech, Inc.
K152764 also covers:
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- EXACTECHGPS — Exactech, Inc.
- GPS — Exactech, Inc.
- GPS — Exactech, Inc.
- GPS — Exactech, Inc.
- GPS — Exactech, 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
- Exactech, Inc.
Sources (1)
- FDA UDI 23e86f5f-d679-4ce4-89cb-b56469b7859d 36 fields · synced Jun 1, 2026