Identity
- Trade Name
- INVISx™ FDA UDI
- Generic Name
- Cranial bone flap fixation clip FDA UDI
- Device Name
- LOCKS 60101 INVISX - 1 FDA UDI
- Model / Reference
- 60101 FDA UDI
- Description
- LOCKS 60101 INVISX - 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169466296 FDA UDI
- 510(k) Number
- K010361 FDA UDI
- FDA Product Code
- GXN FDA UDI
- GMDN Term
- Cranial bone flap fixation clip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5330 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 2.54 Millimeter FDA UDI
Category: Cranial bone flap fixation clip
INVISx™ by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bone flap fixation clip.
- CirFIX® Cranial bone fixation system: Flap Fixator — OSSAWARE BIOTECH CO., LTD. · Class II
- CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS) — OSSAWARE BIOTECH CO., LTD. · Class II
- INVISX™ — Medtronic PS Medical · Class II
- INVISX™ — Medtronic PS Medical · Class II
- INVISx® — Medtronic PS Medical · Class II
Cleared under the same submission
K010361 also covers:
- INVISX™ — Medtronic PS Medical
- INVISX™ — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- INVISx® — Medtronic PS Medical
- InvisX — Medtronic PS Medical
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
- Medtronic PS Medical
Sources (1)
- FDA UDI de37044c-ace3-49f1-966b-9717829b2464 36 fields · synced May 30, 2026