Identity
- Trade Name
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM FDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- SUCCESSION 4/5MM ML DRILL LONG FDA UDI
- Model / Reference
- OS353003L-S FDA UDI
- Description
- SUCCESSION 4/5MM ML DRILL LONG FDA UDI
Identifiers
- Catalog Number
- OS353003L-S FDA UDI
- Primary DI / UDI-DI
- 05055662970609 FDA UDI
- 510(k) Number
- K250622 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cannulated surgical drill bit, single-use
Ortho Solutions Succession Afn System by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, single-use.
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- Sierra™ — SeaSpine Orthopedics Corporation · Class II
- VersiTomic Low Profile Ø11.0 mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- FOREFOOT SOLUTIONS™ — Newdeal Sas · Class I
- APEX 3D S Total Ankle Replacement System — Paragon 28 · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K250622 also covers:
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS SUCCESSION AFN SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho Solutions Holdings Limited
Sources (1)
- FDA UDI ae0076d1-6cf1-4e68-8123-479c01dec264 36 fields · synced May 30, 2026