Identity
- Trade Name
- DELTA FDA UDI
- Generic Name
- Bone tap, single-use FDA UDI
- Device Name
- S-DRILLING TAP, HEX, FOR 8/10mm SCREW FDA UDI
- Model / Reference
- 70-92041 FDA UDI
- Description
- S-DRILLING TAP, HEX, FOR 8/10mm SCREW FDA UDI
Identifiers
- Catalog Number
- 70-92041 FDA UDI
- Primary DI / UDI-DI
- 07613252598268 FDA UDI
- 510(k) Number
- K993061 FDA UDI
- FDA Product Code
- DZJ FDA UDI
- GMDN Term
- Bone tap, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
- Length — 130.0 Millimeter FDA UDI
Category: Bone tap, single-use
Delta by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K993061 also covers:
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
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
- Stryker Leibinger
Sources (1)
- FDA UDI 6b04ecf1-a268-4403-bbea-80e0b3ae7776 36 fields · synced Jun 1, 2026