← Back to catalogue

Ogmend®

FDA UDI

Class II (US FDA UDI)

by Woven Orthopedic Technologies, LLC

Identity

Trade Name
Ogmend® FDA UDI
Generic Name
Bone screw fixation sleeve FDA UDI
Device Name
The Ogmend® Inserter Instrument or Inserter is a single use Class I Medical Device tool used to insert the Ogmend® Implant into a prepared bone hole during a given procedure. The inserter is a simple rod fabricated from passivated 304 stainless steel (full hard/spring temper) and is 8.0 inches in length, 0.080 inches in diameter with rounded edges on each end. The Inserter is used in conjunction with either size of the Ogmend® Sleeve (Medium & Large) to place the respective sleeve into a prepared bone hole. FDA UDI
Model / Reference
50-1003 FDA UDI
Description
The Ogmend® Inserter Instrument or Inserter is a single use Class I Medical Device tool used to insert the Ogmend® Implant into a prepared bone hole during a given procedure. The inserter is a simple rod fabricated from passivated 304 stainless steel (full hard/spring temper) and is 8.0 inches in length, 0.080 inches in diameter with rounded edges on each end. The Inserter is used in conjunction with either size of the Ogmend® Sleeve (Medium & Large) to place the respective sleeve into a prepared bone hole. FDA UDI

Identifiers

Primary DI / UDI-DI
00810050690027 FDA UDI
510(k) Number
K223075 FDA UDI
FDA Product Code
QVI FDA UDI
GMDN Term
Bone screw fixation sleeve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3043 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

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.080 Inch FDA UDI
Length — 8.0 Inch FDA UDI

Category: Bone screw fixation sleeve

Ogmend® by Woven Orthopedic Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone screw fixation sleeve.

Cleared under the same submission

K223075 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Woven Orthopedic Technologies, LLC

Sources (1)

  • FDA UDI dd679913-006e-415a-b59a-ef9fa50cf58f 36 fields · synced Jun 8, 2026