EDGE SURGICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3014282569	3014282569	EDGE SURGICAL, INC.	1	N	2026-01-01	10 Burlington Mall Rd Ste 206 Burlington MA US 01803

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00865707000414	EDG® Ortho 65mm - The EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriately length of screw in orthopedic procedures. This device comes sterile and ready to use once removed from its packaging.	855-765-3249	info@edgesurgical.com

edgesurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
215850	1002288719	K091992	EIDOSMED, MODEL EDG4.0	OOL	2009-12-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OOL	2	2009-12-09

GUDID#

EDG® Ortho 65mm - EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 1mm offset depth gauge.
EDGE SURGICAL, INC.
2025-05-07
EDG® Ortho 65mm - EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 4mm offset depth gauge
EDGE SURGICAL, INC.
2025-05-07
EDG® Ortho 65mm - EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 1mm offset depth gauge.
EDGE SURGICAL, INC.
2025-05-07
EDG® Ortho 65mm - EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 4mm offset depth gauge
EDGE SURGICAL, INC.
2025-05-07
EDG® Ortho 65mm - The EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriately length of screw in orthopedic procedures. This device comes sterile and ready to use once removed from its packaging.
EDGE SURGICAL, INC.
2018-02-28