Identity
- Trade Name
- PKS DRF 2-ID6.9 FDA UDI
- Generic Name
- Optical surgical navigation device tracking system FDA UDI
- Model / Reference
- MAS0004-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290019120049 FDA UDI
- 510(k) Number
- K222355 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
MR Unsafe FDA UDI
Category: Optical surgical navigation device tracking system
Pks Drf 2-Id6.9 by Pathkeeper Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical surgical navigation device tracking system.
- NextAR RSA Platform — Medacta International · Class II
- NextAR Spine Platform — Medacta International · Class II
- HOLO Portal — Surgalign Spine Technologies · Class II
- NextAR Spine Platform — Medacta International · Class II
- NextAR Spine Platform — Medacta International · Class II
- NextAR Spine Platform — Medacta International · Class II
- NextAR Spine Platform — Medacta International · Class II
- NextAR RSA Platform — Medacta International · Class II
Cleared under the same submission
K222355 also covers:
- PKS Accessories Setup DRF — PATHKEEPER SURGICAL LTD
- PKS Accessories Setup DRF — PATHKEEPER SURGICAL LTD
- PKS DRF 2 - ID 5.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 2-ID5.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 3 - ID 12.2 — PATHKEEPER SURGICAL LTD
- PKS DRF 3-ID12.2 — PATHKEEPER SURGICAL LTD
- PKS DRF 3-ID15 — PATHKEEPER SURGICAL LTD
- PKS DRF 3-ID15 — PATHKEEPER SURGICAL LTD
- PKS DRF 4 - ID 7.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 4-ID7.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 4-ID9.5x8 — PATHKEEPER SURGICAL LTD
- PKS DRF 4-ID9.5x8 — PATHKEEPER SURGICAL LTD
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
- Pathkeeper Surgical Ltd
Sources (1)
- FDA UDI 16456e1c-6f2e-4b2b-b6a5-6c8ea05159e9 33 fields · synced Jun 8, 2026