ROMD, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008959459	3008959459	ROMD, LLC	1	N	2026-01-01	2967 Waterview Drive Rochester Hills MI US 48309

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
00812352020007	Royal Oak Pedicle Screw System - Set Screw	2489511550	customerservice@royaloakmed.com
00812352020014	Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø5.5x30mm	248-951-1550	customerservice@royaloakmed.com
00812352020076	Royal Oak Pedicle Screw System - Set Screw - Identical to part number PS5.5-4001.	2489511550	customerservice@royaloakmed.com
00812352020083	Royal Oak Pedicle Screw System - Cross Connector, Fixed 28mm	2489511550	customerservice@royaloakmed.com
00812352020090	Royal Oak Pedicle Screw System - Cross Connector, Fixed 31mm	2489511550	customerservice@royaloakmed.com
00812352020106	Royal Oak Pedicle Screw System - Cross Connector, Fixed 34mm	2489511550	customerservice@royaloakmed.com
00812352020113	Royal Oak Pedicle Screw System - Cross Connector, Fixed 37mm	2489511550	customerservice@royaloakmed.com
00812352020120	Royal Oak Pedicle Screw System - Cross Connector, Fixed 40mm	2489511550	customerservice@royaloakmed.com

royaloakmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
129794	1289298967	K110177	HELENA SYSTEM	MAX	2011-04-21
129794	1614354780	K110046	ATHENA PEDICLE SCREW SYSTEM	NKB	2011-12-07
129794	1065821232
129794	1544026864
129794	1571361450
129794	1590765881

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NKB	1	2011-12-07
MAX	1	2011-04-21

GUDID#

Royal Oak Pedicle Screw System - Set Screw
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø5.5x30mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Set Screw - Identical to part number PS5.5-4001.
ROMD, LLC
2015-10-21
Royal Oak Pedicle Screw System - Cross Connector, Fixed 28mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Cross Connector, Fixed 31mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Cross Connector, Fixed 34mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Cross Connector, Fixed 37mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Cross Connector, Fixed 40mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Cross Connector, Variable, 40-45mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Cross Connector, Variable, 43-50mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Cross Connector, Variable, 58-80mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Curved Rod Ø5.5 x 40 mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Curved Rod Ø5.5 x 45 mm
ROMD, LLC
2014-09-19
Royal Oak Pedicle Screw System - Curved Rod Ø5.5 x 50 mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Curved Rod Ø5.5 x 60 mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Curved Rod Ø5.5 x 70 mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Curved Rod Ø5.5 x 80 mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Curved Rod Ø5.5 x 90 mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø4.5x30mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø4.5x35mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø4.5x40mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø4.5x45mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø4.5x50mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø5.5x35mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø5.5x40mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø5.5x45mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø5.5x50mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø6.5x30mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø6.5x35mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø6.5x40mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø6.5x45mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø6.5x50mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø6.5x55mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø7.5x30mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø7.5x35mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø7.5x40mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø7.5x45mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø7.5x50mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - 5.5mm Pedicle Screw Assembly Ø7.5x55mm
ROMD, LLC
2014-09-20
Royal Oak Pedicle Screw System - Straight Rod Ø5.5x100mm
ROMD, LLC
2014-09-20

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