Identity
- Trade Name
- Adjustable Depth Stop FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Adjustable Depth Stop FDA UDI
- Model / Reference
- 317-0009 FDA UDI
- Description
- Adjustable Depth Stop FDA UDI
Identifiers
- Catalog Number
- 317-0009 FDA UDI
- Primary DI / UDI-DI
- 00816950029400 FDA UDI
- 510(k) Number
- K210247 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Category: Surgical depth gauge, reusable
Adjustable Depth Stop by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, reusable.
- Depth Gauge — I.T.S. GmbH · Class I
- FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
- FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Cleared under the same submission
K210247 also covers:
- 13.0mm Tap Cannulated — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 100mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 105mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 110mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 75mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 90mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 100mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 105mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 75mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 80mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 90mm — OsteoCentric Technologies,Inc
- 2.0 x 130mm Drill Bit Calibrated — OsteoCentric Technologies,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 I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 69b7047f-629a-43f1-8391-114f916bd208 36 fields · synced May 30, 2026