Identity
- Trade Name
- Spartan Stem Broach FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Model / Reference
- 111-44-2007 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215064464 FDA UDI
- 510(k) Number
- K192883 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic broach
Spartan Stem Broach by Signature Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic broach.
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Cleared under the same submission
K192883 also covers:
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
- Spartan Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTD
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 I | Pending data |
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Manufacturer
- Manufacturer
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI 98fe4742-e6f5-4e24-bc56-2d2efc07204f 33 fields · synced May 30, 2026