PECA®2.0 PS060140

GUDID 03700879515267

Beveled compressive implant Ø4 lg40

NOVASTEP

Orthopaedic bone screw (non-sliding)
Primary Device ID03700879515267
NIH Device Record Keya254dce4-7627-4ffa-aee3-8b693be566c0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePECA®2.0
Version Model NumberPS060140
Catalog NumberPS060140
Company DUNS264255288
Company NameNOVASTEP
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com
Phone+33299338650
Emailregulatory-IntFA@enovis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103700879515267 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-12-15
Device Publish Date2025-11-07

On-Brand Devices [PECA®2.0]

03700879516233Bunion implant Ø4 lg30
03700879517957Lid
03700879517940Tray
03700879515335Beveled compressive implant Ø4 lg60
03700879515328Beveled compressive implant Ø4 lg55
03700879515311Beveled compressive implant Ø4 lg50
03700879515304Beveled compressive implant Ø4 lg48
03700879515298Beveled compressive implant Ø4 lg46
03700879515281Beveled compressive implant Ø4 lg44
03700879515274Beveled compressive implant Ø4 lg42
03700879515267Beveled compressive implant Ø4 lg40
03700879515250Beveled compressive implant Ø4 lg38
03700879515243Beveled compressive implant Ø4 lg36
03700879515236Beveled compressive implant Ø4 lg34
03700879515229Beveled compressive implant Ø4 lg32
03700879515212Beveled compressive implant Ø4 lg30
03700879515205Beveled compressive implant Ø4 lg28
03700879515199Beveled compressive implant Ø4 lg26
03700879515182Beveled compressive implant Ø4 lg24
03700879515175Beveled compressive implant Ø4 lg22
03700879515168Beveled compressive implant Ø4 lg20
03700879515151Beveled compressive implant Ø4 lg18

Trademark Results [PECA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PECA
PECA
98493443 not registered Live/Pending
Harvest Partners, LP
2024-04-10
PECA
PECA
98493443 not registered Live/Pending
New Mountain Finance Advisors BDC, L.L.C.
2024-04-10
PECA
PECA
79132922 4545743 Live/Registered
CALZATURIFICIO CARMENS S.P.A.
2013-04-30
PECA
PECA
79033768 3288442 Dead/Cancelled
Max Frank Pressig GmbH
2006-08-24

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.