FDA.reportPublic FDA data

PULSE

Primary DI
00195377153920
Brand
PULSE
Company
Nuvasive, Inc.
Model
5050448
Device description
PULSE Rod Reg Frame, 4.75mm Tall
Published
2023-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230989000Rod Registration FrameNu Vasive, Incorporated2023-05-05OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195377153920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195377153920001953771539201953771539200195377153920

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1(858)909-1800nuvainfo@globusmedical.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517614360Propel50200012015-09-24
00887517614377Propel50200052015-09-24
00887517614384Propel50200102015-09-24
00887517939951AttraX50151102018-06-05
00887517939968AttraX50151202018-06-05
00887517939975AttraX50151302018-06-05
00887517939982AttraX50151032018-06-05
00887517939999AttraX50151042018-06-05
00887517940001AttraX50151062018-06-05
00887517940018AttraX50151012018-06-05
00887517940025AttraX50151022018-06-05
00887517970435Propel50202052018-12-20
00887517970442Propel50202059942018-12-20
00887517970459Propel50202102018-12-20
00887517970466Propel50202109942018-12-20
00887517970473Propel50203012018-12-20
00887517970480Propel50203019942018-12-20
00887517970497Propel50203052018-12-20
00887517971500Propel50203059942018-12-20
00887517971517Propel50203102018-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810141048102Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048126Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048133Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048140Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048157Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048171Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048225Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048232Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048249Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048256Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048263Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048270Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048287Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048294Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048300Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048317Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048324Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048331Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
M946109900N1TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee System (10ea)THINK SURGICAL, INC.OLO2026-11-05
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00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31