Identity
- Trade Name
- S-ROM FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- S-ROM SELF-TAPPING DOME SCREW - LOW PROFILE 6.5mm x 15mm FDA UDI
- Model / Reference
- 55-6070 FDA UDI
- Description
- S-ROM SELF-TAPPING DOME SCREW - LOW PROFILE 6.5mm x 15mm FDA UDI
Identifiers
- Catalog Number
- 556070 FDA UDI
- Primary DI / UDI-DI
- 10603295175902 FDA UDI
- 510(k) Number
- K951000 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone screw (non-sliding)
S-Rom by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K951000 also covers:
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, INC.
- S-ROM — DEPUY ORTHOPAEDICS, 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 |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI a08456e5-b95e-466c-8011-72b3b8e6a2b9 36 fields · synced Jun 8, 2026