Identity
- Trade Name
- airlock® FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- Sterile positionning pin - cutting guide FDA UDI
- Model / Reference
- SKW09001 FDA UDI
- Description
- Sterile positionning pin - cutting guide FDA UDI
Identifiers
- Catalog Number
- SKW09001 FDA UDI
- Primary DI / UDI-DI
- 03700879515120 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
airlock® by Novastep — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic intraoperative positioning pin, single-use.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Prodigy Pedicle Screw System — Curiteva, LLC · Class II
- Guide Screw Headless Threaded — Gebr. Brasseler GmbH & Co. KG · Class II
- K-Wire, 0.9mm x 120mm Long — AVANTI ORTHOPAEDICS LLC · Class II
- Guide Screw — Gebr. Brasseler GmbH & Co. KG · Class II
- TMC PSI Cut Guide System — TREACE MEDICAL CONCEPTS, INC. · Class I
- Stratum — Medartis Inc. · Class I
- AETOS Shoulder System — Smith & Nephew, Inc. · Class I
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
- Novastep
Sources (1)
- FDA UDI 295c68ce-7dc8-44bf-86d4-96a3ae6dcbc7 35 fields · synced May 30, 2026