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APEX 3D Total Ankle Replacement System
FDA UDIClass I (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- APEX 3D Total Ankle Replacement System FDA UDI
- Generic Name
- Surgical saw blade, sagittal, single-use FDA UDI
- Device Name
- Saw Blade 13 x 90mm, 1.27mm, Stryker FDA UDI
- Model / Reference
- P99-151-P104-S FDA UDI
- Description
- Saw Blade 13 x 90mm, 1.27mm, Stryker FDA UDI
Identifiers
- Catalog Number
- P99-151-P104-S FDA UDI
- Primary DI / UDI-DI
- 00889795110862 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Surgical saw blade, sagittal, 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Surgical saw blade, sagittal, single-use
APEX 3D Total Ankle Replacement System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical saw blade, sagittal, single-use.
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KG · Class I
- Stryker Performance Series — Stryker Corp. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KG · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · 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
- Paragon 28
Sources (1)
- FDA UDI 4512a453-9a09-4bf8-b977-312443432848 34 fields · synced May 30, 2026