Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Coated hip femur prosthesis, modular FDA UDI
- Device Name
- SMPL, REVELATION microMAX, STD. NECK, SZ 10.5 LT FDA UDI
- Model / Reference
- 427-31-105S FDA UDI
- Description
- SMPL, REVELATION microMAX, STD. NECK, SZ 10.5 LT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912080484 FDA UDI
- 510(k) Number
- K083651 FDA UDI
- FDA Product Code
- KWA FDA UDILZO FDA UDILPH FDA UDIKWZ FDA UDI
- GMDN Term
- Coated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 888.3330 FDA UDI888.3353 FDA UDI888.3358 FDA UDI888.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coated hip femur prosthesis, modular
Djo Surgical by Djo, Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated hip femur prosthesis, modular.
- LCU Hip Stem — WALDEMAR LINK GmbH & Co. KG · Class II
- ABG — Howmedica Osteonics Corp. · Class II
- Z1™ Hip System — Zimmer, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- VerSys® — Zimmer, Inc. · Class II
- CATALYSTEM — Smith & Nephew, Inc. · Class II
- Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Excia® L — AESCULAP, INC. · Class II
Cleared under the same submission
K083651 also covers:
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 0e8e3b89-8c9a-490c-9fc7-f95b04734554 34 fields · synced Jun 6, 2026