Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- ALTIVATE ANATOMIC AG, CENTER PEG DRILL GUIDE, FW-7MM, RIGHT FDA UDI
- Model / Reference
- 804-09-022 FDA UDI
- Description
- ALTIVATE ANATOMIC AG, CENTER PEG DRILL GUIDE, FW-7MM, RIGHT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446729044 FDA UDI
- 510(k) Number
- K222592 FDA UDI
- FDA Product Code
- KWS FDA UDIPAO FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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: Surgical drill guide, reusable
Djo Surgical by Encore Medical, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
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- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Cleared under the same submission
K222592 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 II | Pending data |
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Manufacturer
- Manufacturer
- Encore Medical, L.p.
Sources (1)
- FDA UDI 63ee47bb-8d29-4a31-8b5b-a3c4b69e65ac 34 fields · synced Jun 6, 2026