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Stablecut® AMK®

FDA UDI

Class I (US FDA UDI)

by Synvasive Technology, Inc.

Identity

Trade Name
Stablecut® AMK® FDA UDI
Generic Name
Surgical saw blade, oscillating, single-use FDA UDI
Model / Reference
562746501 FDA UDI

Identifiers

Primary DI / UDI-DI
00846795023554 FDA UDI
FDA Product Code
GFA FDA UDI
GMDN Term
Surgical saw blade, oscillating, 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

Dimensions & Sizes

Size
Length — 90 Millimeter FDA UDI
Width — 13 Millimeter FDA UDI

Category: Surgical saw blade, oscillating, single-use

Stablecut® AMK® by Synvasive Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical saw blade, oscillating, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synvasive Technology, Inc.

Sources (1)

  • FDA UDI b4e16cd5-7507-44b0-a77e-e2dac25d09ed 34 fields · synced Jun 8, 2026